Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy

Size: px
Start display at page:

Download "Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy"

Transcription

1

2 Trial name: HOVON xxx yyy Sponsor: HOVON Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy QRMP authors Name Role Principal Investigator Trial Manager Statistician Central Data Manager Monitor QRMP approval by sponsor Name Role Signature Page 2 of 28

3 Completion guideline Table 1 - Risk assessment Quality Risk Management Plan HOxxx Table 1 contains a pre-defined list of trial aspects to consider during risk assessment. Trial specific items may be added to the list, but pre-defined aspects should not be removed from the list. Risk identification Describe the perceived risks for each aspect listed in the template. What can go wrong? Why? See appendix 1 for examples of questions to ask. Use a new line for each separate risk. If there are no risks for a pre-defined trial aspect, record this as no risk. If the pre-defined aspect does not exist in the trial, record this as not applicable. Probability Score the probability that this risk will occur in this trial: 1=low 2=medium 3=high Impact Score the severity of the impact on patient safety and/or data validity if this risk occurs in this trial: 1=low 2=medium 3=high Risk score Add the score of Probability + Impact 2-3=mild 4=moderate 5-6=severe Risk mitigation level Choose one of three options how you will handle this risk. Accept: Limit: Avoid: You choose to accept this risk and will not take any measures to reduce the probability and/or impact. Suitable for mild risks. You choose to take measures to reduce the probability and/or impact of this risk to an acceptable level. The amount of risk reduction and the effort and cost you will spend on it, depends on the risk score. Suitable for any risk score. This risk is unacceptable and you will take measures to reduce the probability of this occurring to (almost) zero. This may include changing the intended design or procedures, and it may involve a substantial effort or cost. Suitable for severe risks. Table 2 - Risk mitigation Risk List all risks from table 1 for which the risk mitigation level was set to limit or avoid. Use a short description that links it to the longer description from the risk identification column in table 1. Risk mitigation strategy Describe the measure you will take to limit or avoid the risk. See appendix 2 for examples. Please note that any substantial changes to the trial design or trial procedures may introduce new risks or change the scores of risks, and may therefore require a revision of the risk assessment. Page 3 of 28

4 Table 1 - Risk assessment Trial aspect Risk identification Probability Impact Risk score Risk mitigation level Patient rights Informed Consent Privacy Safety Adverse Reactions Lack of efficacy Compliance to safety measures Safety reporting Safety management Protocol compliance Eligibility Treatment schedule Test procedures Data validity Timely data collection Adequate source documents Accurate CRF completion Reliable central data management Validity of results Power Blinding Sources of bias or variance Page 4 of 28

5 Trial aspect Risk identification Probability Impact Risk score Risk mitigation level GCP compliance Qualifications Resources Essential documents Page 5 of 28

6 Table 2 - Risk mitigation Risk Risk mitigation strategy Page 6 of 28

7 Appendix 1 Guidance for risk assessment Please note that this is only a guidance to help you think through the potential risks in a trial. It is an extensive list but it can never be complete. Trial aspect Patient rights Informed Consent Privacy Risk identification questions to ask Will patients be included requiring non-standard informed consent procedures, such as children or patients (temporarily) unable to give consent due to cognitive disorders? Is there limited time for patients to consider consent, due to urgency to start treatment? Are trial specific procedures needed to screen patients for eligibility, that would require pre-screening consent? Does the trial use multiple consent forms, such as pre-study ICF or separate PK sampling ICF? Does the ICF contain one or more optional items the patient should indicate yes-or-no consent for? Are there any aspects of the trial that are complex and perhaps difficult to understand for the average patient? Are there any unusual aspects in the informed consent process for this trial? Will any personal data be collected centrally, such as or address for distribution of patient questionnaires? Does the trial involve central collection of materials or documents that may contain patient personal data and need to be anonymized and coded by the site, such as CT images, lab reports, biological samples? Are there any additional expenses for the patient due to trial participation? Are there any other aspects in the trial that may pose a risk for upholding patient rights? Page 7 of 28

8 Trial aspect Safety Adverse Reactions Lack of efficacy Risk identification questions to ask Is there an increased risk of adverse reactions compared to standard care? Could there be an increased risk of unexpected adverse reactions compared to standard care? Is the trial intervention a licensed medicinal product or a standard procedure? If yes, to what extent is it used in a different way than in standard practice? How much is known about the expected adverse reactions in the context of the population and indication it is used for in the trial? If the investigational product is used in combination with other medications, how much is known about possible interactions? Does the trial require additional or more frequent test procedures(biopsies, scans etc) compared to standard care? Does this increase the risk of adverse reactions? Is there an increased risk of lack of efficacy of the treatment compared to standard care? Is the trial intervention a licensed medicinal product or a standard procedure? If yes, to what extent is it used in a different way than in standard practice? How much is known about the expected efficacy in the context of the population and indication it is used for in the trial? If the investigational product is used in combination with other medications, how much is known about possible interactions that may affect efficacy? Page 8 of 28

9 Trial aspect Compliance to safety measures Safety reporting Risk identification questions to ask Does the protocol have eligibility criteria for safety reasons that are different or more stringent compared to standard practice? Does the protocol require adherence to dosing instructions or dose modification rules for safety reasons, that is different or more stringent compared to standard practice? Does the protocol require additional or more frequent procedures (pregnancy test, blood chemistry test etc) for safety reasons, compared to standard practice? Do patients need to adhere to specific guidelines for safety reasons, such as storage or use of study drug at home, diet restrictions, use of contraceptives? Are there any specific safety measures in handling the study drug or study product for health care staff that they may be unfamiliar with or unaware of? Does the study drug or study product require specific storage conditions or preparation to warrant its quality, that is different or more stringent compared to standard practice, or that the site staff may be unfamiliar with or unaware of? Are there any other required safety measures that may be difficult to comply with? Are there any Adverse Events of special interest that require expedited (immediate) reporting by the site, even if they do not qualify as an SAE? Are there any safety data other than SAEs that need very timely reporting because they can influence decisions about the continuation of the trial? For example DLT information or AEs for the first treatment cycle in a trial with treatment cohorts. Does the trial require reporting of (S)AEs that are commonly exempt from reporting in trials from this sponsor? Such as progression of disease under study, nausea, CTCAE grade 1 AEs. Are there expected AEs for the trial population that qualify as SAE according to the protocol but may not be readily recognized as such by the investigators? Such as a short hospital admission due to neutropenic fever in leukemia patients. Are there any unusual or complex safety reporting procedures in the trial? Take into account if sites are participating that are unfamiliar with the sponsor s (S)AE reporting forms or procedures. What are the required timelines for reporting of AEs (AE CRF completion) to ensure that complete data are available for review of the overall safety of the trial? Is there a risk that these timelines will not be met? Page 9 of 28

10 Trial aspect Safety management Risk identification questions to ask Do the people involved in the collection, cleaning and assessment of safety data have sufficient knowledge of safety management procedures, the medical context of the trial and the investigational product? Are roles and responsibilities regarding safety management clear to all involved? Are there multiple parties and/or multiple countries involved in the trial with different requirements regarding the handling and reporting of safety information? Is there a risk that these requirements will not be met? Are the facilities and resources available to comply with regulatory safety reporting requirements? How will the sponsor keep track of the overall safety of the trial? If there is a safety concern that is only visible in aggregated data, such as an increase in frequency or severity of an AE above normal expectations, or a difference between the treatment arms, would you be able to detect it in time? Are there any unusual or complex safety management procedures in the trial? Is the trial blinded? Is there a clear and robust procedure regarding unblinding for SAE and SUSAR reporting? Are there any other aspects in the trial that may pose a risk for the safety of patients or the safety of people in the patient s surroundings or the safety of health care staff? Page 10 of 28

11 Trial aspect Protocol compliance Eligibility Treatment schedule Risk identification questions to ask Is there a risk that patients are enrolled that are in fact not eligible? Is there a risk that eligible patients are not enrolled because eligibility could not be confirmed in time? Does the protocol have eligibility criteria that are different or more stringent compared to standard practice? Does confirmation of eligibility require complex or time-consuming or unusual assessments? Is there a limit on the time passed between the date of an assessment and the date of enrolment to pass the eligibility criterion? For example WBC needs to be >1.0 x 109/l and assessment of WBC should be done no more than 7 days prior to enrolment. Does the protocol have eligibility criteria that are not defined by hard values but require medical judgment of the investigator? How difficult is this assessment for the investigators compared to standard practice? Is there any incentive for investigators to enroll patients that are not eligible? Either for their own benefit or for the assumed benefit of the patient, for example a lack of treatment options in standard practice? How different is the protocol treatment schedule from standard practice? A schedule that is very much like standard practice but has a few (important) changes, can pose a risk because the differences are overlooked and the usual routine is followed. A schedule that is very different and therefore unfamiliar, can pose other risks, specifically if it is complex. Are there many or complex decision points? Do decision points require a complex or unfamiliar assessment? Is there a risk that a decision is made based on an incorrect assessment or conclusion? For example a CR is required to continue to maintenance treatment and response needs to be assessed according to protocol criteria that are more stringent than standard practice. Page 11 of 28

12 Trial aspect Test procedures Risk identification questions to ask Does the protocol require additional or more frequent procedures (bone marrow smear, CT scan, etc) compared to standard practice? Does the protocol require complex or time-consuming or unusual assessments compared to standard practice? Does the assessment of any of the endpoints require central sample collection? Are any of the requirements for the collection (method, timing) or storage or handling or shipping of the samples complex or time-consuming or unusual? Are any assessments, that are essential for patient safety or validity of results, burdensome for the patient? Is there a risk of patient refusal? Are the sites compensated by the sponsor for the costs of additional assessments? Which specific protocol deviations would have a direct impact on patient safety or validity of the trial results? For example incorrect dosing in a dose finding trial. Does the protocol require additional patient visits compared to standard practice? This can mean more frequent visits or a longer continuation of follow up visits after the end of treatment. Are there any other aspects of the trial that may pose a risk for the adherence to the protocol? Page 12 of 28

13 Trial aspect Data validity Timely data collection Adequate source documents Accurate CRF completion Risk identification questions to ask Is there a risk that data are not collected within the required timelines? The required timelines are determined by scheduled (interim) analyses but also by the need to monitor the safety, protocol compliance and progress of the trial. Is the CRF extensive (many data) or complex? Are sites participating that are unfamiliar with the sponsor s data collection form design, e-crf system or procedures? Do data for a single patient need to be collected from multiple sources by the site (local data manager)? For example treatment in different hospitals or data generated by an off-site lab. Are source data for a single patient recorded in multiple locations or in multiple systems/files on site? Are all data sources known and available for the local data manager? Does the trial require to collect source data that are more extensive than standard practice? Are source data for a single patient generated at multiple locations? For example treatment in different hospitals or data generated by an off-site lab. Are source data for a single patient produced by multiple health care professionals? For example attending physicians, nurses, lab technicians. Are all persons involved in source data production sufficiently aware of the requirements for the trial? Is the CRF extensive (many data) or complex? Are sites participating that are unfamiliar with the sponsor s data collection form design, e-crf system or procedures? Are all data sources known and available for the local data manager? Do the people involved in CRF completion have sufficient knowledge of good data management practice and the medical context of the trial? Does the trial require collection of data that may be difficult to extract from the source data or that need interpretation of source data (medical judgment)? Is CRF completion adequately supervised and supported by the investigator(s) on site? Page 13 of 28

14 Trial aspect Reliable central data management Central data management: any storage and handling of data from the CRF to the dataset for statistical analysis, including data collection, data entry, data cleaning, data transfer or data extraction, data transformation Risk identification questions to ask Is there a risk of data corruption or loss of data due to a malfunction or calamity? Is there a risk of transcription errors or other inadvertent changes in the data in the process of data transfer from the CRF to the dataset as used for analysis of results? Is there a risk that data are intentionally modified without it being reported or detected? For example modifying response assessments in the database or in the dataset for analysis, without documentation that data were modified compared to the CRF. Is there a risk that over time or between patients data are not consistently collected or cleaned or assessed according to the same criteria? In blinded trials, is there a risk that the blind is inadvertently broken during the data management process? Do the people involved in the collection and cleaning of data have sufficient knowledge of data management procedures and the medical context of the trial? Do the people involved in managing the (digital) storage and transfer of data have sufficient knowledge of relevant data management procedures and do they have the relevant technical knowledge of the systems used? Are roles and responsibilities regarding data management clear to all involved? Are there any unusual or complex data management procedures in the trial? Are there any other aspects of the trial that may pose a risk for the validity of the data? Page 14 of 28

15 Trial aspect Validity of results Power Risk identification questions to ask Is there a risk that the target recruitment number needed for successful analysis of the trial is not sufficient? For example if dropout rate or event rate is not as expected. Is there a risk of not meeting the target recruitment or recruitment rate? Contributing factors can be: competing trials, insufficient compensation of costs, insufficient number of participating sites, slow activation of sites, high burden for patients, trial difficult to explain to patients, restrictive eligibility criteria. Is there a risk that too many patients are enrolled that are in fact not eligible? See eligibility for risk factors. Is there a risk that the blind is prematurely broken for too many patients? See blinding for risk factors. Is there a risk that too many patients have insufficient data to be evaluable for the study endpoints? You can make a distinction in the risk score for the primary endpoint and secondary endpoints. Is there a risk of premature withdrawal from treatment or loss to follow up of patients? Contributing factors can be: high burden for the patient from trial procedures or from additional hospital visits, inadequate management of expected adverse events, insufficient site awareness of the relevance of follow up information, trial participation does not match patient s expectations (informed consent process, patient information sheet). Is there a risk of non-compliance to the protocol resulting in missing data? See protocol compliance Is there a risk that the CRF design does not capture all the data required for analysis of the endpoints? Is there a risk that available data are not collected? See data validity? Page 15 of 28

16 Trial aspect Blinding Risk identification questions to ask Is there a risk, also in an open-label trial, that investigators are exposed to aggregate data or reports that may prematurely reveal (interim) results concerning the endpoints? Is there a risk that a patient requires emergency treatment by a physician not involved in the trial? Is there a risk that an investigator is unable to get an emergency unblinding for a patient? Are all involved site staff aware of the emergency unblinding procedure? Are instructions how to perform an emergency unblinding readily available at the site? Are all people involved in the emergency unblinding procedure aware of their responsibilities? Is the emergency unblinding procedure robust with regards to 24/7 availability of the service? Is the emergency unblinding procedure complex? Is there a risk that the blind is intentionally broken for a patient without it being reported or detected? Is there a risk that the blind is inadvertently broken? And is there a risk that this happens without it being reported or detected? Could a clinical event inadvertently break the blind? Page 16 of 28

17 Trial aspect Sources of bias or variance Risk identification questions to ask Which specific protocol deviations would be a potential cause of bias or too much variance in the data? See protocol compliance Specifically mind non-compliance regarding eligibility in trials where there is a multi-step process in treatment allocation and inclusion. For example registration for screening prior to enrolment, late randomization after enrolment, multiple randomizations. Is there a risk that over time or between patients data are not consistently collected or cleaned or assessed according to the same criteria? See reliable central data management Do the endpoints rely on hard values or do they require medical judgment? Is there a risk that the decision of the patient or investigator to prematurely withdraw from treatment is influenced by the randomization arm or by being exposed to interim results of the trial? Is there a risk of unbalanced randomization results? Is there a risk that investigators can influence or predict the randomization result? Is there a risk that a patient is randomized with an incorrect stratification factor? Is there a risk that this will occur multiple times? Is there a risk that the blind is broken for multiple patients without it being recorded? Also see blinding Are there any other aspects of the trial that may pose a risk for the validity of the results? Page 17 of 28

18 Trial aspect GCP compliance Qualifications Resources Essential documents Risk identification questions to ask Is there a risk that trial related tasks are performed by persons without adequate training or qualifications? Are there non-standard procedures in the trial that require additional training? Is there a risk that there is insufficient supervision of the quality of delegated tasks by the investigator? Is there a risk that the site does not have the required resources (time) or facilities for the trial? Is there a risk that essential documents are incomplete, absent or get lost? Specifically mind drug accountability records, delegation logs and signed informed consent forms. Are there any other aspects of the trial or the trial sites that may pose a risk for GCP compliance? Are there any other aspect of the trial that may pose a risk to patient safety or to the validity of the trial results? Page 18 of 28

19 Appendix 2 - Examples of risk mitigation strategies Please note that these are only examples. solutions or variations on the examples may be more suitable for your trial specific risks. Trial aspect at risk Informed Consent Privacy Adverse Reactions Lack of efficacy Possible risk mitigation strategies Robust design of IC documents and procedures, including peer review (PUC) and patient review of ICF. Training of site staff on ICF form and procedures. IC obtained by GCP trained investigators only. Review of site s IC process on-site (SEV) Collect and verify date of IC in enrolment database. Partial or complete review of trial specific signed ICFs on-site (trial specific monitoring visits). Robust design of systems and procedures used for collecting personal data, including testing of system security. Robust design of forms and procedures used for sample/materials collection. Training of site staff and/or central facility staff regarding coding procedures. Review of proper coding of materials received by central facility staff, followed up by trial team. Review of materials received at central facility by trial team or monitor ( audit ) Robust protocol design including safety measures and risk-benefit assessment, reviewed by EC and peer reviewed by writing committee, PUC. Review of safety data: annual safety reports reviewed by EC, interim analyses and DSMB review, continuous manual review of reported SAEs by PI. Note: requires timely and accurate data collection. Robust protocol design including risk-benefit assessment, reviewed by EC and peer reviewed by writing committee, PUC. Review of efficacy data: interim analyses and DSMB review. Note: requires timely and accurate data collection. Page 19 of 28

20 Trial aspect at risk Compliance to safety measures Possible risk mitigation strategies Robust protocol design regarding need and feasibility of safety measures and eligibility criteria, peer reviewed by writing committee, PUC. Review of adequate site facilities and/or site acceptance of protocol procedures, by site selection questionnaire and/or pre-study site visit, and/or review of information from SEV. Eligibility assessed by investigators only. Provide written instructions for patients, either in ICF or as separate document (NB EC approval). Provide written instructions for site staff (manual) regarding product handling. Training of site staff on patient safety measures and/or product handling. Review of site s general performance on protocol compliance on-site (SEV) Review of site s general process of eligibility assessment on-site (SEV) Review of site s general facilities and procedures on product handling on-site (SEV) Partial or complete review of trial specific protocol compliance, including eligibility, on-site (trial specific monitoring visits) Either scheduled or triggered (for cause visit) Partial or complete review of trial specific adherence to product handling instructions on-site (trial specific monitoring visits) Either scheduled or triggered (for cause visit) Partial or complete review of CRF data to verify protocol compliance, including eligibility, (remote monitoring) Note: requires timely and accurate data collection and implemented procedures for remote monitoring. Periodic or triggered (from data review) phone calls to site to review/request feedback on protocol compliance or product handling issues (remote monitoring) Partial or complete central collection and review of drug accountability records and/or patient diaries (remote monitoring, NB privacy) Collect and review data to verify eligibility prospectively in enrolment database. Page 20 of 28

21 Trial aspect at risk Safety reporting Possible risk mitigation strategies Robust protocol design regarding need and feasibility of safety reporting criteria, peer reviewed by writing committee, PUC. Robust design of safety data collection forms and reporting procedures, peer reviewed by PUC. Site staff involved in safety reporting is qualified by prior training and experience: general review of CV, delegation of tasks on-site during SEV. Alternatively, central collection and review of delegation log and CV copies. Alternatively, confirmation of prior good performance of sites as assessed by co-sponsor. Training of site staff on safety data collection forms and reporting procedures. Provide detailed safety CRF/report completion guidelines for site staff. Safety data requiring medical judgment assessed by investigators only (policy) Confirmation of safety data review by investigator (signature for CRF or final SAE report required) Periodic review and follow up of timely safety data collection (AE CRF, DLT CRF, SAE follow up) Review of collected safety data for discrepancies and/or signals of missed reports, internal (AE CRF discrepancy checks) or cross-check (AE-SAE, SAE-DLT, etc) Note: requires timely and accurate data collection and implemented procedures for remote monitoring. Review of site s relative performance compared to other sites on timely SAE reporting based on database review (annually in SEV) Review of site s general process of safety reporting on-site, including procedures for safety reporting if a patient is treated at multiple locations/sites (SEV) Partial or complete review of complete and accurate safety reporting on-site (trial specific monitoring visits with source data verification) Either scheduled or triggered (for cause visit) Note: optimal use of visits triggered by central review of data requires implemented procedures for remote monitoring. Page 21 of 28

22 Trial aspect at risk Safety management Possible risk mitigation strategies Robust safety management procedures, including trial specific procedures in blinded trials. Staff involved in safety management is qualified by prior training and experience. Trial specific training of staff involved in safety management in procedures, medical context, product information. Record and discuss delegation of tasks and responsibilities. Investigate, discuss and record trial specific safety management requirements. Safety cases requiring medical judgment, including SUSARs, reviewed by PI or (in blinded trial) independent medical reviewer. Review of safety data: annual safety reports reviewed by EC, interim analyses and DSMB review, continuous manual review of reported SAEs by PI. Note: requires timely and accurate data collection. Periodic review of safety database by safety desk coordinator for compliance to sponsor safety assessment procedures and SUSAR reporting timelines. Page 22 of 28

23 Trial aspect at risk Protocol compliance in general (including eligibility, treatment schedule, test procedures) Eligibility compliance Possible risk mitigation strategies Robust protocol design regarding need and feasibility of eligibility criteria, treatment schedule and test procedures, peer reviewed by writing committee, PUC. Robust design of IC documents, including peer review (PUC) and patient review of ICF, to ensure that patient knows what to expect, improve patient compliance and reduce premature withdrawal. Review of adequate site facilities for protocol procedures and/or site acceptance of protocol procedures including acceptance of available reimbursement of additional costs, by site selection questionnaire and/or prestudy site visit, and/or review of information from SEV. Training of site staff on critical protocol procedures. Assessments/decisions requiring medical judgment made by investigators only (policy) Review of site s general performance on protocol compliance, on-site (SEV) Review of site s general process of making trial related decisions, on-site (SEV) Partial or complete review of trial specific protocol compliance on-site (trial specific monitoring visits with source data verification) Either scheduled or triggered (for cause visit) Note: optimal use of visits triggered by central review of data requires implemented procedures for remote monitoring. Review of CRF data to detect recurrent issues with protocol compliance on site or trial level (remote monitoring) Note: requires timely and accurate data collection and cleaning and implemented procedures for remote monitoring. Periodic or triggered (from data review) phone calls to site to review/request feedback on protocol compliance issues (remote monitoring) Central review or central assessment of complex assessments (NB privacy), either prospective or retrospective. Eligibility assessed by investigators only. Review of site s general process of eligibility assessment on-site (SEV) Review of CRF data to verify eligibility for each patient (central data management) Note: requires timely and accurate data collection. Collect and review data to verify eligibility prospectively in enrolment database. Page 23 of 28

24 Trial aspect at risk Treatment schedule compliance Timely data collection Adequate source documents Possible risk mitigation strategies Partial or complete central collection and review of drug accountability records and/or patient diaries (remote monitoring, NB privacy) Periodic central review and follow up of timely data collection. (e-)crf and completion guidelines available prior to enrolment of first patient. Database and data management plan (procedures) available prior to enrolment of first patient. Review of adequate site resources for timely CRF completion and acceptance of CRF completion timelines, by site selection questionnaire and/or pre-study site visit, and/or review of information from SEV. Training of site staff on CRF completion timelines. Review of site s general process for CRF completion on-site, including communication lines between local data manager and clinical staff (SEV) Review of site s general quality of source documents on-site, including procedures for exchanging information if a patient is treated at multiple locations/sites (SEV) Training of investigators and other clinical staff. Provide templates for source document worksheets. Page 24 of 28

25 Trial aspect at risk Accurate CRF completion Possible risk mitigation strategies Robust design of CRF and reporting procedures, peer reviewed by PUC. Site staff involved in CRF completion is qualified by prior training and experience: general review of CV, delegation of tasks on-site during SEV. Alternatively, central collection and review of delegation log and CV copies. Alternatively, confirmation of prior good performance of sites as assessed by co-sponsor. Training of site staff on CRF completion and reporting procedures. Provide detailed CRF completion guidelines for site staff. Data requiring medical judgment assessed by investigators only (policy) Confirmation of CRF data review by investigator (signature for CRF required) Review of collected data for discrepancies (front-end edit checks in e-crf, queries, data cleaning). Review of site s general process for CRF completion on-site, including communication lines between local data manager and clinical staff (SEV) Partial or complete review of complete and accurate data reporting on-site (trial specific monitoring visits with source data verification) Either scheduled or triggered (for cause visit) Note: optimal use of visits triggered by central review of data requires implemented procedures for remote monitoring. Page 25 of 28

26 Trial aspect at risk Reliable central data management Power Possible risk mitigation strategies Robust procedure for database back-ups and restoring. Formal validation of database and data handling software. Functional test of trial database and discrepancy checks (no formal validation) Functional test of data handling software (no formal validation) Robust security settings for database access. Database audit trail. Data entry validation/review. Staff involved in central data management is qualified by prior training and experience. Trial specific central data managements procedures are recorded in data management plan and approved by statistician and PI, including procedures for maintaining the blind in a blinded trial. The data management plan is version controlled and implementation of changes recorded. Trial specific training of staff involved in central data management on data management plan and medical context of the trial. Record and discuss trial specific delegation of tasks and responsibilities. Mutual peer review of adherence to central data management procedures (trial specific and general) and good CDM practice by trial team, statisticians and PI. Data inconsistencies requiring medical judgment reviewed by PI. Review of enrolment database for recruitment rates. Periodic review of premature withdrawal rates (for example coinciding with annual progress report or DSMB review)note: requires timely and accurate data collection. Event rate monitoring by statistician. Note: requires timely and accurate data collection. Periodic or triggered (from data review) phone calls to site to review/request feedback on recruitment or premature withdrawal issues (remote monitoring) Page 26 of 28

27 Trial aspect at risk Blinding Bias and variance Possible risk mitigation strategies Robust data confidentiality procedures. Training of site staff in data confidentiality principles and procedures. Mutual peer review of adherence to data confidentiality policy. Robust (trial specific) procedures for maintaining the blind. Robust (trial specific) emergency unblinding procedure. Training of site staff on emergency unblinding procedure. Provide written instructions for emergency unblinding for site staff. Publish on publicly accessible part of HOVON website. Provide patient wallet cards with instructions in case of an emergency (phone number) NB EC approval. Periodically test availability of emergency unblinding service. Review of adherence to blinding and unblinding procedures and review of records on-site at the facility providing the service. Partial review to assess general process or complete review for all patients. NB review should not inadvertently break the blind. Robust randomization procedure. Review of CRF data to verify stratification factors for each patient (central data management) Note: requires timely and accurate data collection. Collect and review data to verify stratification prospectively in enrolment database. Page 27 of 28

28 Trial aspect at risk Qualifications Resources Essential documents Possible risk mitigation strategies General review of CV of all site staff (prior training and experience including GCP training) on-site during SEV and for echelon classification (NL only) General review of delegation of tasks and supervision by investigator on-site during SEV and for echelon classification (NL only) Central collection and review of delegation log and CV copies investigators CV only or also other site staff. Confirmation of site staff qualifications and prior good performance of sites as assessed by co-sponsor. Trial specific training of site staff. Trial specific review of site staff qualifications (CV and/or interview) and evidence of investigator supervision onsite (trial specific monitoring visits) Either scheduled or triggered (for cause visit) Note: optimal use of visits triggered by central review of data requires implemented procedures for remote monitoring. General review of availability of resources for trials during SEV and for echelon classification (NL only) Review of adequate site facilities and staff availability for protocol procedures and/or site acceptance of protocol procedures including acceptance of available reimbursement of additional costs, by site selection questionnaire and/or pre-study site visit, and/or review of information from SEV. Periodic or triggered (from data review) phone calls to site to review/request feedback on issues with available resources (remote monitoring) Review of site s general process and performance in maintaining essential trial documents, on-site (SEV) Central collection and review of (copies of) critical documents prior to site activation or in case of amendments (remote monitoring) Training of site staff. Provide site with self-assessment checklist of required essential documents, periodically and/or at the end of the trial. Trial specific review of essential documents availability on-site (trial specific monitoring visits) Either scheduled or triggered (for cause visit) Page 28 of 28

Quality Monitoring Checklist

Quality Monitoring Checklist Quality Monitoring Checklist Instructions: For each task below, the Quality Monitor indicates in the appropriate column if the Monitor accomplished the task by using the following codes Yes No N/A = Monitor

More information

Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS

Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS Training Course in Sexual and Reproductive Health Research Geneva 2012 OUTLINE Clinical Data Management CDM

More information

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities

More information

Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS

Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS Training Course in Sexual and Reproductive Health Research Geneva 2013 OUTLINE Overview of Clinical Data

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

DHHS/NIH/OD/OIR/OHSRP 1/2/2015

DHHS/NIH/OD/OIR/OHSRP 1/2/2015 DHHS/NIH/OD/OIR/OHSRP 1/2/2015 The audience for this course is Principal Investigators (PIs), investigators and Research Coordinators (RCs) serving on the study team of human clinical studies and trials.

More information

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:

More information

No. 706. Page 1 of 5. Issue Date 4/21/2014

No. 706. Page 1 of 5. Issue Date 4/21/2014 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute PURPOSE Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page

More information

TEMPLATE DATA MANAGEMENT PLAN

TEMPLATE DATA MANAGEMENT PLAN TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager

More information

Managing & Validating Research Data

Managing & Validating Research Data Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical

More information

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations Maria Luisa Paoloni OPBG Clinical & Research Services Monitoring and Responsible of monitoring:

More information

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's

More information

DAIDS Appendix 2 No.: DWD-POL-DM-01.00A2. Data Management Requirements for Central Data Management Facilities

DAIDS Appendix 2 No.: DWD-POL-DM-01.00A2. Data Management Requirements for Central Data Management Facilities DAIDS Appendix 2 No.: DWD-POL-DM-01.00A2 Data Management Requirements for Central Data Management Facilities The following clinical trial data management requirements must be met in order to ensure the

More information

The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial

The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial Clinical Research Operations & Regulatory Support (CRORS) Ann Glasse, RN, BSN, MBA Director-CRORS Objectives

More information

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name

More information

INTERIM SITE MONITORING PROCEDURE

INTERIM SITE MONITORING PROCEDURE INTERIM SITE MONITORING PROCEDURE 1. PURPOSE The purpose of this SOP is to describe the interim monitoring procedures conducted at Institution, according to GCP and other applicable local regulations.

More information

Laurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute

Laurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute Laurie Shaker-Irwin, Ph.D., M.S. Co-Leader, Regulatory Knowledge and Research Ethics UCLA Clinical and Translational Science Institute Understand the protocol completely Recognize institutional polices

More information

Data Management & Case Report Form Development in Clinical Trials. Introduction to the Principles and Practice of Clinical Research.

Data Management & Case Report Form Development in Clinical Trials. Introduction to the Principles and Practice of Clinical Research. Data Management & Case Report Form Development in Clinical Trials Introduction to the Principles and Practice of Clinical Research February 3, 2015 Marge Good, RN, MPH, OCN Nurse Consultant Division of

More information

Data Management Unit Research Institute for Health Sciences, Chiang Mai University

Data Management Unit Research Institute for Health Sciences, Chiang Mai University Data Management Unit Research Institute for Health Sciences, Chiang Mai University Clinical Data Management is the process of handling data from clinical trials. The inherent goal of any clinical data

More information

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV)

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Study Start-Up SS-204.01 STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell,

More information

CNE Disclosures. To change this title, go to Notes Master

CNE Disclosures. To change this title, go to Notes Master CNE Disclosures Successful Completion: Participants must complete an evaluation form to receive a certificate of completion Contact Hours: 1 contact hour is available to those who meet the successful completion

More information

This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled.

This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

More information

CONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator

CONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator Research Department STANDARD OPERATING PROCEDURE STH Investigator Archiving of Essential Documentation Generated During Clinical Research SOP Number A127 Version Number V1.3 Effective Date Author Zoe Whiteley

More information

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH Martin Valania, Executive Director, Corporate QA and Compliance Introduction Pharmaceutical companies recognize the benefits of carefully managing

More information

12.0 Investigator Responsibilities

12.0 Investigator Responsibilities v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,

More information

The Study Site Master File and Essential Documents

The Study Site Master File and Essential Documents The Study Site Master File and Essential Documents Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 002 Version number: 1 Effective date: 01 June 2010

More information

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure

More information

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.

More information

Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA

Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA This presentation is the property of DynPort Vaccine Company LLC, a CSC company, and

More information

Orientation Manual for Clinical Research Coordinators

Orientation Manual for Clinical Research Coordinators Orientation Manual for Clinical Research Coordinators Maine Medical Center Research Institute Page 1 of 19 Version 1 (2009) MAINE MEDICAL CENTER RESEARCH INSTITUTE Statement of Mission, Vision, Goals and

More information

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol University of Hawai i Human Studies Program Guidelines for Developing a Clinical Research Protocol Following are guidelines for writing a clinical research protocol for submission to the University of

More information

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,

More information

TRIAL MASTER FILE- SPONSORED

TRIAL MASTER FILE- SPONSORED gsop-06-04 - Management of TMF for ENHT/ WHHT Sponsored CTIMPs Page 1 of 16 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust TRIAL MASTER

More information

Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity

Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good

More information

ICH CRA Certification Guide March 2009

ICH CRA Certification Guide March 2009 ICH CRA Certification Guide March 2009 ICH CRA CERTIFICATION GUIDE... 1 GENERAL INFORMATION... 2 BENEFITS OF CERTIFICATION... 2 INDUSTRY RECOGNITION... 2 ABOUT THE EXAM... 2 CRA DEFINITION... 2 REQUIREMENTS

More information

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,

More information

Guidance on IRB Continuing Review of Research

Guidance on IRB Continuing Review of Research NOTE: THIS GUIDANCE SUPERSEDES OHRP S JANUARY 15, 2007 GUIDANCE ENTITILED GUIDANCE ON CONTINUING REVIEW. CLICK HERE FOR THE JANUARY 15, 2007 GUIDANCE. Office for Human Research Protections Department of

More information

Challenges and Opportunities in Clinical Trial Data Processing

Challenges and Opportunities in Clinical Trial Data Processing Challenges and Opportunities in Clinical Trial Data Processing Vadim Tantsyura, Olive Yuan, Ph.D. Sergiy Sirichenko (Regeneron Pharmaceuticals, Inc., Tarrytown, NY) PG 225 Introduction The review and approval

More information

Standard Operating Procedures (SOP) Research and Development Office

Standard Operating Procedures (SOP) Research and Development Office Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Undertaking Risk Assessment of a Research and Development Project SOP Number: 33 Version Number: 1.0 Supercedes: N/A Effective

More information

Data Management in Clinical Trials

Data Management in Clinical Trials Data Management in Clinical Trials Introduction to the Principles and Practice of Clinical Research February 19, 2013 Diane St. Germain, RN, MS Nurse Consultant Division of Cancer Prevention National Cancer

More information

Essential Documents for the Conduct of a Clinical Trial. Debra Dykhuis Associate Director RSO

Essential Documents for the Conduct of a Clinical Trial. Debra Dykhuis Associate Director RSO Essential Documents for the Conduct of a Clinical Trial Debra Dykhuis Associate Director RSO Introduction Rationale for choosing this topic AHC movement toward setting GCP (Good Clinical Practice) guidelines

More information

2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials

2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials L1 2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager,

More information

DAIDS Bethesda, MD USA. POLICY Requirements for Clinical Quality Management Plans

DAIDS Bethesda, MD USA. POLICY Requirements for Clinical Quality Management Plans CHANGE SUMMARY: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. Key changes to the policy require all sites to submit a bi-annual Clinical

More information

Comprehensive Study Documents List (Biomedical Studies)

Comprehensive Study Documents List (Biomedical Studies) Comprehensive Study Documents List (Biomedical Studies) Investigators conducting human subjects research must maintain study documents in adherence to federal and state regulations, USC policies, and good

More information

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities This Guidance Document is to ensure that investigators and research personnel recognize their responsibilities associated with the conduct of human subject research by outlining their responsibilities,

More information

New Investigator Collaborations and Interactions: Regulatory

New Investigator Collaborations and Interactions: Regulatory Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials

More information

CLINICAL RESEARCH PROTOCOL CHECKLIST

CLINICAL RESEARCH PROTOCOL CHECKLIST CLINICAL RESEARCH PROTOCOL CHECKLIST [taken from ICH GCP : Guidance for Industry, Good Clinical Practice: Consolidated Guidance, Revision 1 (R1) June 1996] ICH GCP, Section 6. CLINICAL TRIAL PROTOCOL AND

More information

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP.

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP. Role of IRB/IEC in GCP Benjamin Kuo, MD, Dr.PH, CIP. Institutional Review Board (IRB) An independent body constituted of medical, scientific and non scientific members Responsible for ensuring protection

More information

How To Write A Binder Tab

How To Write A Binder Tab Tool Summary Sheet Tool: Extramural Essential Documents Binder/File Tabs Purpose: To provide an organizational framework and guidance for filing paper versions of essential study documents (or referencing

More information

What is necessary to provide good clinical data for a clinical trial?

What is necessary to provide good clinical data for a clinical trial? What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction

More information

Operational aspects of a clinical trial

Operational aspects of a clinical trial Operational aspects of a clinical trial Carlo Tomino Pharm.D. Coordinator Pre-authorization Department Head of Research and Clinical Trial Italian Medicines Agency Mwanza (Tanzania), June 11, 2012 1 Declaration

More information

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,

More information

ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014

ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014 ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014 1. Introduction The St. Michael s Hospital (SMH) REB

More information

The Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis

The Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis The Monitoring Visit Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis Disclosure The information herein is not intended to

More information

The Importance of Following the PROTOCOL in Clinical Trials

The Importance of Following the PROTOCOL in Clinical Trials The Importance of Following the PROTOCOL in Clinical Trials Presentation Objectives: Upon completion of this presentation, participants will be able to: Describe the following terms: Protocol, Protocol

More information

UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE

UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL)

More information

STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders

STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders STANDARD OPERATING PROCEDURE FOR RESEARCH Management of Essential Documents and Trial Folders Author Linda Ward Author s Job Title QA Coordinator Division Department Version number 2 Ref SOP/CLN/001/2

More information

SOP Number: SOP-QA-20 Version No: 1. Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen)

SOP Number: SOP-QA-20 Version No: 1. Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen) Standard Operating Procedure: SOP Number: SOP-QA-20 Version No: 1 Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen) Approved by: Date: 1-9-15 (Professor Julie Brittenden,

More information

NEGOTIATING CLINICAL TRIAL BUDGETS. Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N.

NEGOTIATING CLINICAL TRIAL BUDGETS. Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N. NEGOTIATING CLINICAL TRIAL BUDGETS Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N. A.B.N. Amateur Budget Negotiator OVERVIEW Budget Types Analyzing the Protocol Negotiating the Contract Discussion / Tips

More information

The New EU Clinical Trial Regulation Potential Impacts on Sites

The New EU Clinical Trial Regulation Potential Impacts on Sites The New EU Clinical Trial Regulation Potential Impacts on Sites Angela Papa Associate Director, Clinical Management PPD Pierre-Frédéric Omnes Director, Site Start-Up and Regulatory INC Research Faculty

More information

Principal Investigator and Sub Investigator Responsibilities

Principal Investigator and Sub Investigator Responsibilities Principal Investigator and Sub Investigator Responsibilities I. Purpose To define the roles and responsibilities of Principal Investigators conducting research at GRU. II. Definition The term Principal

More information

Clinical Data Management Overview

Clinical Data Management Overview The 2 nd Clinical Data Management Training Clinical Data Management Overview Andrew Taylor ( 安 泰 乐 ), M.S. Head of Clinical Data Management August 30, 2010 Learning Objectives Overview of Process Related

More information

Appendix 1 Waiver of the requirement for informed consent for a clinical trial in a medical emergency Page 1 of 2

Appendix 1 Waiver of the requirement for informed consent for a clinical trial in a medical emergency Page 1 of 2 Appendix 1 Waiver of the requirement for informed consent for a clinical trial in a medical emergency Page 1 of 2 The Helsinki Committee may approve a clinical trial without the requirement to obtain informed

More information

History and Principles of Good Clinical Practice

History and Principles of Good Clinical Practice History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices

More information

Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership

Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership PROJECT MANAGEMENT - SCOPE DEFINITION AND MANAGEMENT Understands the

More information

Remote Monitoring of Clinical Trials and EMRs

Remote Monitoring of Clinical Trials and EMRs Remote Monitoring of Clinical Trials and EMRs Sandra SAM Sather, MS, BSN, CCRA, CCRC Vice-President Clinical Pathways LLC samsather@clinicalpathwaysresearch.com Lindsey Spangler, J.D. Associate Director,

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 27 July 2005 Doc. Ref. EMEA/CHMP/EWP/5872/03 Corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE

More information

Use of Electronic Health Record Data in Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

Yale Cancer Center Data and Safety Monitoring Committee Charter

Yale Cancer Center Data and Safety Monitoring Committee Charter Yale Cancer Center Data and Safety Monitoring Committee Charter Purpose/Mission The purpose of the Yale Cancer Center (YCC) Data and Safety Monitoring Committee (DSMC) is to provide ongoing data and safety

More information

R&D Administration Manager. Research and Development. Research and Development

R&D Administration Manager. Research and Development. Research and Development Document Title: Document Number: Patient Recruitment SOP031 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager,

More information

through advances in risk-based

through advances in risk-based Insight brief Quintiles is a market leader with >100 risk-based monitoring studies Quintiles developed solutions that bring as much as 25% cost reduction over traditional trial execution approaches Transform

More information

This policy applies to all clinical research conducted at Beaumont Health System.

This policy applies to all clinical research conducted at Beaumont Health System. CLINICAL RESEARCH QUALITY AND PROCESS IMPROVEMENT PROGRAM 113 1 of 6 PURPOSE Prior The purpose of this policy is to provide an overview of the Clinical Research Quality and Process Improvement Program

More information

Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects

Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects U.S. Department of Health and Human Services Food and Drug Administration Center for Drug

More information

Health Care Job Information Sheet #20. Clinical Research

Health Care Job Information Sheet #20. Clinical Research Health Care Job Information Sheet #20 Clinical Research A. Background B. Occupations 1) Clinical Research Associate (Study Monitor) 2) Clinical Research Coordinator 3) Other positions in the field C. Labour

More information

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain P a g e 1 PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain Clinical Phase 4 Study Centers Study Period 25 U.S. sites identified and reviewed by the Steering Committee and Contract

More information

STANDARD OPERATING PROCEDURE NO. CM.13-00 - 00

STANDARD OPERATING PROCEDURE NO. CM.13-00 - 00 STANDARD OPERATING PROCEDURE NO. CM.13-00 - 00 Version date: Effective Date: Replaces SOP No.: 1 5 January 20 13 15 February 20 13 Approved by: Date No: CM.13 00 00 Effective Date: 15 February 2013 Version

More information

Document Title: Trust Approval and Research Governance

Document Title: Trust Approval and Research Governance Document Title: Trust Approval and Research Governance Document Number: SOP034 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D

More information

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,

More information

Claim of Exemption Form Page 1 of 6

Claim of Exemption Form Page 1 of 6 Claim of Exemption Form Page 1 of 6 Principal Investigator: Phone: Project or Protocol Title: Contact Person: Address: Phone: Fax: E-mail: Copy of Principal Investigator s CV attached SPONSOR / FUNDING

More information

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s Author: Lisa Austin, Research Manager Purpose and Objective: To identify and standardise

More information

Electronic Medical Records and Source Data for Research: What s the Difference?

Electronic Medical Records and Source Data for Research: What s the Difference? Electronic Medical Records and Source Data for Research: What s the Difference? Tammy Anderson, CCRC, CCRA, CRCP Director, Clinical Trials Office Virginia Commonwealth University Research Coordinator 4

More information

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans NOTE: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. DAIDS has clearly stated the minimum requirements for the CQMP and provided examples

More information

Infoset builds software and services to advantage business operations and improve patient s life

Infoset builds software and services to advantage business operations and improve patient s life Infoset builds software and services to advantage business operations and improve patient s life Clinical Data Management ecrf & EDC Patient Support Programs Medication Adherence Mobile e-health Big Data

More information

Objectives. Monitoring & Auditing of Clinical Trials. Overview. Pre-study Qualification Visit. Industry-sponsored Trials

Objectives. Monitoring & Auditing of Clinical Trials. Overview. Pre-study Qualification Visit. Industry-sponsored Trials Objectives Monitoring & Auditing of Clinical Trials Sponsored by Center for Cancer Research National Cancer Institute Guidelines suggest that following the good clinical research practice of monitoring/auditing

More information

Conduct of clinical Trials Communication of

Conduct of clinical Trials Communication of PrinciPles on Conduct of clinical Trials Communication of clinical Trial results Table of Contents Preamble...1 Commitment to Protecting Research Participants...5 Conduct of Clinical Trials...7 Ensuring

More information

Clinical Trials: Questions and Answers

Clinical Trials: Questions and Answers Clinical Trials: Questions and Answers Key Points Clinical trials are research studies that test how well new medical approaches work in people (see Question 1). Every clinical trial has a protocol, which

More information

Document Number: SOP/RAD/SEHSCT/007 Page 1 of 17 Version 2.0

Document Number: SOP/RAD/SEHSCT/007 Page 1 of 17 Version 2.0 Standard Operating Procedures (SOPs) Research and Development Office Title of SOP: Computerised Systems for Clinical Trials SOP Number: 7 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013

More information

Supplement to the Guidance for Electronic Data Capture in Clinical Trials

Supplement to the Guidance for Electronic Data Capture in Clinical Trials Supplement to the Guidance for Electronic Data Capture in Clinical Trials January 10, 2012 Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Note: The original language of this

More information

Introduction. The Evolution of the Data Management Role: The Clinical Data Liaison

Introduction. The Evolution of the Data Management Role: The Clinical Data Liaison Introduction The CDL is a new role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money. A CDL is key in that he or she conducts

More information

A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky

A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky I. Compliance with IRB and Applicable Federal Requirements A. Investigators

More information

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device

Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation

More information

Clinical trials: from European perspective to National implementation. CTFG / FAMHP / pharma.be. Brussels, 19 November 2010

Clinical trials: from European perspective to National implementation. CTFG / FAMHP / pharma.be. Brussels, 19 November 2010 Clinical trials: from European perspective to National implementation CTFG / FAMHP / pharma.be Brussels, 19 November 2010 Safety in clinical trials: From detection to decision How safety events are captured

More information

Clinical Investigator Inspections and FDA-483 Observations

Clinical Investigator Inspections and FDA-483 Observations Clinical Investigator Inspections and FDA-483 Observations Nancy A. Bellamy, Investigator Bioresearch Specialist/ BIMO Coordinator FDA Detroit District Office October 2, 2013 Objectives Background on FDA

More information

Friday, May 2. Clinical Trials: Is Your Staff Competent? Session 10:15 11:45 am Ballroom C

Friday, May 2. Clinical Trials: Is Your Staff Competent? Session 10:15 11:45 am Ballroom C Session 10:15 11:45 am Ballroom C Clinical Trials: Is Your Staff Competent? What fundamental skills and knowledge should clinical trials nurses have? In response to questions from its members about how

More information

Guidance for Industry Computerized Systems Used in Clinical Investigations

Guidance for Industry Computerized Systems Used in Clinical Investigations Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) May 2007 Guidance

More information

Essential Documents for Clinical Trial Research. Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office

Essential Documents for Clinical Trial Research. Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office Essential Documents for Clinical Trial Research Erin Cherban, MSc., CCRP Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office Document Examples See the following

More information

PREP Course #27: Medical Device Clinical Trial Management

PREP Course #27: Medical Device Clinical Trial Management PREP Course #27: Medical Device Clinical Trial Management Presented by: Evelyn Huang Jeffrey Revello Office of Research Compliance North Shore-LIJ Health System CME Disclosure Statement The North Shore

More information

STUDY PROGRESS AND SAFETY MONITORING PLAN TEMPLATE

STUDY PROGRESS AND SAFETY MONITORING PLAN TEMPLATE STUDY PROGRESS AND SAFETY MONITORING PLAN TEMPLATE (Intended primarily for use in monitoring of Phase III/IV trials) Final December 20, 2006 20 DEC 06; Version 2.0 1 of 15 No.: DWD-POL-SR-01.00A2 TABLE

More information

Industry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels

Industry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Industry Experience in Clinical Trials Management Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Stakeholders in clinical research Critical activities to ensure patient

More information

Document Title: Project Management of Papworth Sponsored Studies

Document Title: Project Management of Papworth Sponsored Studies Document Title: Project Management of Papworth Sponsored Studies Document Number: SOP009 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G

More information