Effective Date: October 2015

Size: px
Start display at page:

Download "Effective Date: October 2015"

Transcription

1 University of Maryland Greenebaum Cancer Center UMGCC Standard Operating Procedure Title: Data & Safety Monitoring Plan Effective Date: October 2015 Procedure No: DSM001 University of Maryland Greenebaum Cancer Center (UMGCC) governs clinical research through a parent Clinical Research Oversight Committee (CROC), which oversees the function of the Clinical Research Management Office (CRMO), and two under committees: the Data & Safety Monitoring/Quality Assurance Committee (DSM/QAC) and the Clinical Research Committee (CRC) that serves as the NCIrequired Protocol Review and Monitoring System (PRMS). These committees oversee the conduct of clinical research at UMGCC. This SOP describes the actions and procedures of the Data and Safety Monitoring/Quality Assurance Committee (DSM/QAC). I. DSM/QAC Scope and Function The DSM/QAC ensures patient and research subject safety and integrity of research in clinical trials conducted by UMGCC. It is the responsibility of the DSM/QAC to review all clinical studies for patient safety and quality control. The DSM/QAC has the authority to request modifications to incorporate safety information, to suspend trials pending investigation of toxicity and corrective action of protocol conduct which has led to deviations from the intended protocol, and to require additional patients be treated at a current or previous cohort for Phase I studies. The DSM/QAC may refer recommendations to the CRC to permanently close trials in which it is felt that the demonstrated risks outweigh the potential benefits of the study or where the expected trial outcomes cannot be achieved with further patient enrollment. The DSM/QAC can refer protocols for re-review by the CRC in the event that there is a question about the continuing scientific value or methodology that may warrant revisions of the protocol or warrant closure of the protocol for loss of scientific progress or priority. The DSM/QAC has the following functional tasks: A. Annual and semi-annual review of research The DSM/QAC provides ongoing safety review for UMGCC protocols which lack their own existing DSMB. These protocols include: Investigator-initiated protocols, except those for which the IRB has granted a waiver of consent (e.g., retrospective chart reviews) p1

2 NCI-sponsored Phase I and Phase II trials not conducted within the purview of an NCI-sponsored cooperative group, or where the relevant NCI-sponsored cooperative group does not have an appropriate external DSM. Industry-sponsored studies for which an external DSM group is not active. Other protocols may be considered for ongoing review at the request of the CRC or the IRB. Review may be conducted more frequently than semiannually if there is a specific reason or request from the CRC or IRB. B. Track Adverse Events Review Internal and External Serious Adverse Event (SAE) and Adverse Event (AE) experiences on the above designated protocol categories either semi-annually (high-risk studies) or annually (routine or low risk studies) to ensure that potential benefits of continuing research projects exceed potential harm from SAE and AE. Review on an ongoing basis external SAE (Outside Safety Reports) and DSM reports submitted to UMGCC investigators by trial sponsors, including reports from independent Data Safety Monitoring Boards for external randomized Phase III trials. For those external SAEs which do not meet IRB reporting criteria for immediate submission, the DSM/QAC will serve as the secondary reviewing entity of record, after the Principle Investigator review of information received from the sponsoring organization. A table of such external SAEs for each protocol is available for submission to the IRB with the protocol annual renewal. Assess Phase I studies for dose limiting toxicities after each cohort prior to dose escalation C. Review of significant findings generated during Internal Monitoring of Investigator Initiated Therapeutic Trials D. Review of significant findings generated during auditing (internal or external) of UMGCC clinical trials. II. Definitions A. Adverse Event Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for p2

3 example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. B. Serious Adverse Event Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity or, is a congenital anomaly or birth defect. Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be life threatening or result in death or hospitalization but may jeopardize the patient or require intervention to prevent one of the other outcomes listed in this definition. C. Clinical Trial The DSM/QAC follows the IRB s definitions for activities constituting human subjects research (i.e., clinical trial) as provided in the University of Maryland, Baltimore Human Research Protections Plan and Human Research Protections Investigators Manual This manual may be accessed at D. Investigator-Initiated Clinical Trial An investigator-initiated (sometime referred to as institutional) clinical trial is defined for the purposes of these guidelines as a clinical research study authored or co-authored by a member of the UMGCC faculty or staff. An investigator-initiated trial is therapeutic if a drug substance is administered or the intent of the protocol activity is to affect therapeutic decision making. E. Quality Assurance Monitoring/Auditing UMGCC monitoring and auditing involves the Quality Assurance Manager (QAM) or non-crmo staff designee scrutinizing the actions of UMGCC investigators, with a requirement that the monitor/auditor be independent of the CRMO management structure and sponsor. F. External Audits p3

4 UMGCC trials may be audited by various external agencies including the IRB, NCI or its contractors, or the FDA. Audit activities typically involve a detailed review of the conduct of the clinical trial, including, but not limited to, subject enrollment, verification of source documentation of eligibility and data collection, review of serious adverse events, review of protocol exceptions and deviations, regulatory documents, drug accountability. G. Principal Investigator (PI) The PI is responsible for collecting and reporting adverse events on his/her clinical trials in a timely fashion to the applicable IRB, UMGCC DSM/QAC, FDA, trial sponsors, as well as all other relevant committees and agencies. H. Clinical Research Management Office(CRMO) The Clinical Research Management Office is the office that supports clinical research conducted by UMGCC faculty and has a staff of more than 30 individuals consisting of regulatory coordinators, study coordinators and data managers. The CRMO maintains a clinical research database of all protocols open at UMGCC. This database allows for the collection of AEs and SAEs, both internal and external, providing a framework for DSM/QAC review. I. Quality Assurance Manager (QAM) The QAM is the individual responsible for coordinating the DSM/QAC meetings, arranging internal monitoring of UMGCC trials as needed, auditing trials according to this DSM plan, assisting CRMO staff with external audits as needed, and providing education and training to UMGCC employees as needed, on preparing trials for audit and other related topics. To provide a degree of independence, this individual has no reporting ties to the CRMO management structure J. Clinical Research Committee (CRC) The CRC is responsible for the scientific review of new protocols. Their review is conducted prior to IRB review to assess CRMO resources to support study conduct. CRC review includes a consideration of the adequacy of the DSM plan proposed by the PI. The CRC may impose a stricter level of monitoring for higher-risk studies. The CRC is also responsible for reviewing accrual to all UMGCC trials on at least an annual basis to assure timely recruitment of subjects to trials. The CRC may be asked by the DSM/QAC or the IRB to provide continuing review of protocols about which questions have arisen in relation to new information received and the continuing scientific value of the research question. K. Clinical Research Oversight Committee (CROC) p4

5 The CROC is responsible for setting policies, processes and Standard Operating Procedures for clinical research at UMGCC and for considering the physical and personnel resource requirements for the CRMO. The CROC also has the authority to consider disciplinary sanctions against clinical investigators. L. Data and Safety Monitoring / Quality Assurance Committee (DSM/QAC) The DSM/QAC consists of a chair and UMGCC staff representing various disciplines and disease groups, including representation from Medical Oncology/ Hematology, Surgical Oncology, Radiation Oncology, and Clinical Pathology Disease Groups, Nursing, Pharmacy, and Supporting Services (Infectious Diseases, Biostatistics, Palliative Care). DSM/QAC activities are coordinated by the QAM. The DSM/QAC meets monthly and requires a quorum of three members. Members may designate a proxy of comparable expertise to attend in their place. See attachment 1 for membership. See figure 1 for overview of research oversight structure (including DSM/QAC) in place at UMGCC. M. University of Maryland Institutional Review Board (UMB IRB) The IRB is a federally required administrative body, accredited by the Association for the Accreditation of Human Research Protection Programs, established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of University of Maryland, Baltimore, which includes UMGCC. The IRB has the authority to approve, require modifications to, suspend, terminate or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. The IRB also may observe or have a third party observe the consent process. N. Human Research Protections Office (HRPO) The HRPO is the coordinating office for the UMB IRB. The HRPO is responsible for providing periodic audits of designated trials. p5

6 Figure 1: Overview of Research Oversight at UMGCC III. DSM/QAC Procedures A. Review of Research 1. - Types of Reviews and Assignment of Risk a. Annual Review (High Risk) Phase II and III therapeutic studies designated as high risk by the Clinical Research Committee (CRC) are reviewed annually by the DSM/QAC for subject accrual, conduct of the trial and safety (internal and external SAE reports). b. Semi-Annual Review (Highest Risk) p6

7 All Phase I therapeutic trials and investigator-initiated Phase II/III therapeutic studies are designated by the CRC as highest risk. Studies designated as highest risk will be reviewed annually for subject accrual and conduct of trial; semi-annually for safety. The DSM/QAC has the discretion to review annually studies classified as highest risk, where the sponsor monitors and conducts cohort reviews, but lacks an independent DSM. c. Phase 1/Cohort Review For Phase 1 trials without an independent DSM, a member of the UMGCC DSM/QAC reviews the toxicity experience in all treated patients prior to escalating into the next cohort The cohort review is done by a single member of the DSM/QAC prior to the scheduled meeting, with results reported to the full DSM/QAC at the next meeting. Documentation of this cohort review is kept in the study file and forwarded to the IRB with the annual report. The PI of a Phase I study must receive explicit approval from the DSM/QAC member before proceeding to the next dose escalation cohort. 2. Annual and Semi-Annual Review Procedures To assure that DSM/QAC and IRB oversight of protocols is optimally coordinated, DSM/QAC annual review is timed for completion prior to the IRB anniversary date. As shown in figure 2 below, for those studies requiring DSM/QAC review, UMGCC clinical investigators compiles the IRB annual renewal submissions 90 days before IRB annual review. The DSM/QAC assigns a committee reviewer who will present their evaluation at the DSM/QAC meeting no later than 60 days prior to the IRB annual review. The DSM/QAC provides feedback and requests for clarification to the PI no later than 45 days prior to IRB annual review. The PI submits response to DSM/QAC inquiries no later than 30 days prior to IRB annual review, and the DSM/QAC reviews the responses at the next meeting, approximately 30 days prior to the IRB anniversary date. 90 days prior 60 days prior 45 days prior 30 days prior PI prepares annual submission DSM/QAC reviews DSM/QAC comments received by PI Fig. 2 Timeline for DSM/QAC annual review process DSM/QAC reviews revised PI submission IRB annual review p7

8 Semi-annual reviews are conducted on the same timeline to coincide with the IRB annual review date and also six months from same. PIs are expected to be available by pager or cell phone for DSM/QAC meetings where their protocols will be discussed. The below items are considered in DSM/QAC annual review. The semi-annual review will include only those items below related to safety. A cover form (Annual Renewal DSM/QAC) completed by the study team summarizing the activities of the prior reporting period. All SAEs and protocol-designated expeditiously reportable AEs, internal and external, including those that have previously been reported to the DSM/QAC. The DSM/QAC will have a full report on all internal SAEs concerning that clinical trial, including the nature of the SAE, grade, therapeutic agents involved, whether they were reported to all appropriate agencies within the mandated timeframes, and the investigator s assessment of whether the toxicity was study related. The DSM/QAC may recommend to the CRC to close studies with adverse event profiles that deviate in a substantial way from expected patterns of events. The consent form to determine if modifications are needed based on the accumulated AEs and SAE information. A summary of protocol deviations that have not yet been reviewed by the DSM/QAC. If available, interim outcomes and other results are assessed to see if response rates conform to estimates used to develop the statistical analysis. The DSM/QAC may recommend study closure to the CRC for studies with poorer than expected response rates that cannot meet stated outcomes targets even if the trial accrued fully. Conversely, response rates significantly greater than expected may lead to early termination of trials to prevent further assignment of patients to the inferior treatment arms in comparative trials. Periodic audit results, if available. The DSM/QAC may recommend study closure to the CRC for studies when the PI or research team show a pattern of persistent non-compliance with Good Clinical Practices policies. Upon conclusion of review, the DSM/QAC decides one of the following: Award final DSM/QAC approval to the protocol Find that minor revisions are needed for final DSMB approval Find that major corrections are needed to the protocol Suspend immediately to prevent harm to subjects or others Recommend closure of the protocol to the CRC due to GCP non-compliance or low accrual. p8

9 Refer the protocol back to the CRC for scientific re-review if new information has called into question the original study hypothesis. DSM/QAC actions are approved by majority committee member vote. Members with conflicts of interest will not serve as reviewers for protocols for which they are conflicted and will recuse themselves from discussions and voting on such studies The record of DSM/QAC actions for a protocol consist of: Chair notes, consisting of findings of the DSM/QAC reviewer, discussions and decisions by the DSM/QAC and specific issues requiring remediation DSM/QAC correspondence with the PI, specifying the actions to be taken (if applicable) and the acceptable turnaround time for response PI responses to DSM/QAC inquiries are reviewed at the next DSM/QAC meeting Final DSM/QAC review outcome provided to the PI Records of these reviews are made available to the IRB for consideration in their deliberations. B. Adverse Event Reporting The requirements for adverse event reporting for clinical trials are complex. In general, the DSM concentrates only on SAEs as defined by the FDA. In the event that the protocol uses other SAE definitions or designates certain AEs as having special reporting requirements even if they do not meet the acceptable definition of SAE, the DSM will consider those as well. The DSM may at any time consider patterns of AEs that warrant protocol or consent changes. DSM/QAC review of protocols includes checking whether AE and SAE reports have been properly reported to the sponsor, the IRB (if applicable), the FDA if applicable, co-investigators at participating institutions, and any applicable government agencies. The PI is ultimately responsible for ensuring that reporting of SAEs and AEs to all applicable bodies occurs within the designated timeframes. If the trial involves federal or other grant funding, the PI is responsible for summarizing adverse events in grant progress reports as per the requirements of the funding agency. 1. Reporting Bodies IRB Reporting: The UMB IRB currently requires expeditious reporting of events that convey information indicating a new or increased risk or a safety issue which may affect research subjects. Similarly, any harm experienced by a subject or other individual, which in the opinion of the investigator is unexpected and probably related to the research procedures must be reported. The UMB IRB also requires reporting of unanticipated adverse device effects. p9

10 All of these reporting requirements can be found at NCI Reporting: The NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs provides instructions for reporting adverse events to NCI for all of its trials. NCI Investigator Handbook (available at outlines specific expedited AE reporting requirements. Investigators and study staff are responsible for being aware of and complying with all requirements of both the IRB and NCI. FDA Reporting: In those cases where the PI or another UMB employee is the IND holder, current FDA reporting requirements (Suspected adverse reaction, Serious and Unexpected) must be met. Sponsor Reporting: Sponsor reporting guidelines are typically established to allow the sponsor to comply with its reporting requirements to the FDA and any applicable international regulatory authorities. 2. SAE Tracking The CRMO research database (OnCore ) has specific capacity to record the reporting dates of serious adverse events for tracking purposes. As it is likely that many events requiring expeditious reporting to the NCI or other sponsors will only be reported to the IRB with the annual renewal, CRMO staff must enter all SAEs in Oncore. The DSM will review summary reports of these events to ensure that proper reporting and assessment occurred. Internal SAEs must be assessed by the PI. The PI will make the determination as to whether the event requires expeditious IRB reporting or not. See figure 3 below for SAE management processes. p10

11 SAE received and logged into Oncore 5 business days Event, attribution, grade, other relevant info assigned by PI and entered into Oncore by data manager Yes PI determines if IRB reportable No PI reports to IRB Expeditiously DSM/QAC reviews to ensure not IRB reportable SAE incl. in IRB annual renewal Figure 3: SAE Management process Upon receipt of the external SAE (Outside Safety Report), the PI is presented with a summary report to allow PI acknowledgement of: Related or unrelated to the study therapy Seriousness Expected or unexpected Required IRB submission immediately or with annual report If requested by the PI, the comprehensive Outside Safety Report is sent to the PI for review. For those external SAEs which do not meet criteria for immediate submission to the IRB, the DSM/QAC serves as the second reviewing entity of record. Summaries of SAE reviews are presented as part of the protocols DSM review as described below. a. DSM/QAC Review of SAE p11

12 Designated DSM/QAC members review SAEs as appropriate for the type of trial and review the following determinations: Related or unrelated to the study therapy Seriousness Expected or unexpected Requires IRB submission immediately or with annual report The DSM/QAC has the authority to temporarily suspend or make a recommendation to the CRC to permanently close trials if review indicates that investigators or research staff have failed to follow adverse event reporting guidelines for the trial. Investigators or research staff who have a history of problems with meeting reporting guidelines will be referred to the CROC for potential disciplinary action. i. Phase I and Investigator Initiated Trials UMGCC regards Phase I trials and Investigator Initiated trials as the highest risk studies, so in addition to NCI- or sponsormandated reporting and review, UMGCC also requires local continuous monitoring of patient safety. The PI or study team provides the DSM with a report of all SAEs at every cohort, 6- month safety and annual review. ii. Phase II and Phase III Trials without external DSM UMGCC regards phase II and III trials without external DSM as high risk studies. As such the DSM/QAC reviews summary reports of all external SAEs on an annual basis. iii. Phase II and Phase III Trials with an external DSM These sponsored studies must have an independent DSM plan in place. Because of this, they are not reviewed by UMGCC DSM/QAC. iv. NCI-Sponsored Cooperative Group Studies The UMGCC has been a member of the Alliance, NRG (National Surgical Adjuvant Breast and Bowel Project - NSABP, Radiation Therapy Oncology Group - RTOG and Gynecology Oncology Group - GOG) and Children s p12

13 Oncology Group (COG). It may participate in occasional studies from other cooperative groups. Each of these groups develops peer-reviewed trials, which include detailed DSM plans. Adverse event reporting to the groups and the NCI is handled as per the specific instructions from the cooperative group. v. Gene Transfer Trials Adverse event reporting for studies involving recombinant DNA-containing products will follow NIH Guidelines for Research Involving Recombinant DNA Molecules in addition to any other applicable federal, state, institutional or sponsor guidelines for adverse event reporting for the trial. Briefly, any serious adverse event that is both unexpected and associated with the use of the gene transfer product (i.e., there is reasonable possibility that the event may have been caused by the use of the product; investigators will not await definitive proof of association before reporting such events) are clearly labeled as a Safety Report and submitted to the NIH Office of Biotechnology Activities (NIH OBA) and to the local Institutional Biosafety Committee. Any serious adverse event that is fatal or life-threatening, that is unexpected, and associated with the use of the gene transfer product are reported to the NIH OBA as soon as possible, but not later than 7 calendar days after the initial receipt of the information (i.e., at the same time the event must be reported to the FDA). Serious adverse events that are unexpected and associated with the use of the gene transfer product, but are not fatal or lifethreatening, are reported to the NIH OBA as soon as possible, but not later than 15 calendar days after the initial receipt of the information (i.e., at the same time the event must be reported to the FDA). vi. Multi-Institutional Investigator Initiated Trials Multi-institutional Investigator Initiated Trials where UMGCC serves as the coordinating center may or may not have industry sponsors. These trials receive the level of oversight appropriate to the risk involved in the trial (i.e., high or highest.). UMGCC follows the NCI guidelines for multi-institutional trials. The Lead Principle Investigator is responsible for the reporting requirements associated with subject safety. p13

14 Participating institutions report all reportable Adverse Events and SAEs to UMGCC who in turn reports to the applicable regulatory bodies. The CRMO research database will be used to collect all reportable AEs and SAEs for the protocol. The Lead Principle Investigator makes the determination if the reportable AE or SAE warrants revision to the protocol and informed consent. UMGCC disseminates this information to all participating centers in the form of a modified protocol and/or consent. To convey safety information in a more timely fashion, the Lead PI may also elect to send a safety letter to all co-investigators notifying them of the event and forthcoming changes to the protocol, if applicable. vii. Ad Hoc Reviews of SAEs The DSM/QAC reviews SAE (internal/external) reports as requested by the principle investigator. This ad hoc review occurs when the PI feels the SAE increases the risk to subject significantly or deems a second opinion on the matter is needed. C. Monitoring and Auditing of UMGCC Clinical Trials 1. Internal Monitoring/Auditing of UMGCC Clinical Trials Industry sponsored clinical trials which have their own independent monitoring service that performs monitoring on a routinely scheduled basis will not be subject to additional internal monitoring without cause. Likewise, NCI-sponsored trials that have periodic computerized data submission and independent auditing groups (e.g., Cooperative Groups) will also not be routinely monitored without cause. However, all therapeutic investigator-initiated trials will be subject to monitoring by the UMGCC at intervals as defined by the protocol monitoring plan. a. Procedures The QAM will be responsible for coordinating the monitoring and auditing of these trials. Designated non-crmo staff members (as identified and trained by the QAM) and/or the QAM will function as monitors and auditors for these trials. Therapeutic Investigator Initiated trials that do not have external monitoring will be monitored on an at least an annual basis. p14

15 b. Notification The Principal Investigator and Study Coordinators are notified in advance of a scheduled monitoring or auditing session in which subjects have been randomly selected for review by the QAM. The QAM, in conjunction with the lead CRA contacts the study team to arrange for a mutually agreed upon time for the session. The investigator and the research staff are responsible for gathering all of the materials germane to the review including medical records, case reports forms, and any other research records requested. If affiliate centers are enrolling subjects, the monitoring plan will outline affiliate site obligations. c. Implementation i. Monitoring: The lead CRA performs quality assurance review on the requested records to ensure compliance. A monitoring report is generated, and any significant findings will be presented at the next DSM/QAC monthly meeting. The monitoring report is sent to the Principal Investigator summarizing the findings and any recommendations. Any queries to the PI will need to be addressed by the next monitoring visit. Accrual findings will be presented to the CRC. Specific information requested includes: Regulatory Folder, to include copy of most current protocol, amendments, Investigator Brochure, availability of form 1572 Accrual listings for selected trails(s) Hospital medical record/access to emr Patient-specific research source binder Access to the Investigational Drug Pharmacy to ensure the presence of drug accountability forms specific to the clinical trial ii. Auditing: In order to assure the proper conduct of the clinical trials under the purview of the DSM/QAC, the QAM or adequately trained designee will perform internal audits of data collected. Specifically, 100% of patients accrued during the preceding calendar year on investigatorinitiated therapeutic trials and approximately 50% of the charts from the preceding calendar year for open and accruing therapeutic trials in the following categories: Phase 2 studies without external data safety monitoring, NCI Phase 1 studies and corporate/industry trials without external data safety monitoring. Standard auditing tools will be used. Specific issues to be examined include: p15

16 The proper maintenance of the regulatory file and database record with all necessary documents on hand, including the original IRB protocol approval, IRB approval of modifications, SAE reports and other regulatory documents Informed Consent Review (e.g. adequate consent form process, proper consent version used, properly executed consent form signed and dated) Documentation that the subject met the protocol required eligibility criteria to be enrolled. Documentation that the protocol-specific therapy was delivered in the specified manner, including doses, schedules and infusion times Documentation that appropriate study-related investigations, i.e., laboratory, radiology and study visits, were accomplished Verification of responses in those studies where clinical responses are to be noted Verification of toxicities where toxicities are an endpoint Verification that all SAE s were reported in a timely fashion. Verification of efficacy and /or endpoint data required per protocol. In the case of an internal audit, the auditor will prepare an audit report that will be presented to the DSM/QAC at the next available meeting if there are significant findings. A copy of this report will also be shared with the PI and CRMO management for consideration. 2. External Auditing of UMGCC Clinical Trials The UMGCC has many trials that are audited by external reviewers, including NCI contractors and industry representatives for data that is to be submitted to the FDA. Any audit report received from a Federal Agency or audit reports meeting IRB specified reporting requirements must be submitted to the IRB and reported to the DSM/QAC. The DSM/QAC has the authority to suspend and ultimately close trials in which adherence to good clinical research practices are lacking. The HRPO/IRB and/or the DSM/QAC may request audit of a trial or an audit of additional charts/trials depending on result or issues that may arise in relation to a particular trial or investigator. IV. DSM/QAC Meetings DSM/QAC agendas for the monthly meetings are maintained by the QAM. This individual maintains, with the assistance of the research database, lists of all protocols that are subject to semi-annual and annual review, all protocols for which the DSM/QAC serves as the DSMB, and all Phase I trials which will require dose escalation approval. All protocols from each of the above categories are added to DSM/QAC agendas at the appropriate time points. The QAM also schedules p16

17 consideration of audit reports and follow-up discussion of PI responses to protocols reviewed at prior meetings. The summary reports of the SAEs that have been assessed in the intervals between meetings is prepared and provided to the DSM by the QAM. Minutes of the DSM/QAC meetings consists of a record of attendance, the chair notes for each of the protocols reviewed, DSM/QAC reviewer summaries of protocol reviews, letters to the PIs, and PI responses received for studies reviewed at earlier meetings, and chair documentation of any other issues discussed. Decision to Suspend or Make Recommendation to Close Should the DSM/QAC exercise its authority to suspend or make a recommendation to the CRC to close a trial under any of the above review mechanisms, the DSM/QAC promptly notifies the IRB of this decision. The DSM/QAC requires the PI notify the sponsor, collaborators, grant program director if applicable, any and all appropriate governmental agencies (i.e. FDA, NCI), and any other appropriate party. The PI provides the DSM/QAC with copies of all such notifications. If the trial is suspended or closed by any other party, the PI is expected to promptly provide the DSM/QAC with copies of the suspension or closure, and documentation that appropriate parties have been notified. The CRMO research database is configured such that a trial that is suspended or closed by the DSM/QAC is unavailable for further patient registration. While the PI is responsible for primary notification to appropriate treating physicians and nurses about protocol closure, the research database provides a secondary notification system. V. Conflict of Interest Policies The DSM/QAC will follow the conflict of interest policies set out by the UMB IRB, which has the responsibility for monitoring conflict of interest. These policies are completely described at All investigators, including those operating or employed outside of UMB, and their study personnel must disclose in advance all outside activities and economic interests that might be or have the appearance of being conflicts of interest as described above to the UMB IRB. If a conflict of interest occurs after the research study has commenced, the investigator must promptly update the COI information in CICERO. A disclosure shall be sufficiently detailed and timely as to allow accurate and objective evaluation prior to making commitments or initiating activities that represent potential conflict situations. The information must be accurate and not known by the Investigator to be false, erroneous, misleading, or incomplete. Each individual has an obligation to cooperate fully with the IRB and the appointed Conflict of Interest (COI) Officer in the review of the pertinent facts and circumstances regarding any conflict of interest disclosed. p17

18 The IRB or designated UMB official will determine whether the disclosed economic interest is likely to compromise or appear to compromise the design, conduct or reporting of the study. The DSM/QAC follows any recommendations from the IRB with respect to conflict of interest and reserves the right to impose even more stringent conflict management. It assures that no reviews or audits are conducted by individuals with conflicts. The DSM/QAC further assures that, even where no economic conflict exists, studies will not be monitored or reviewed by individuals who may have significant scientific interest in the outcome. p18

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

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

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

Policy of the National Institute of Nursing Research for Data and Safety Monitoring of Extramural Clinical Trials

Policy of the National Institute of Nursing Research for Data and Safety Monitoring of Extramural Clinical Trials Policy of the National Institute of Nursing Research for Data and Safety Monitoring of Extramural Clinical Trials Purpose and Scope This policy sets forth the National Institute of Nursing Research (NINR)

More information

DAIDS Bethesda, MD USA POLICY

DAIDS Bethesda, MD USA POLICY Overview NIH policy requiring independent data and safety monitoring boards (DSMB) for all multicenter Phase III trials has existed since 1979; the most recent restatement was issued in 1998 (NIH Policy

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

IOWA STATE UNIVERSITY Institutional Review Board. Reporting Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others

IOWA STATE UNIVERSITY Institutional Review Board. Reporting Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others IOWA STATE UNIVERSITY Institutional Review Board Reporting Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others Introduction This policy details the Institutional Review Board

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

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 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

Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events

Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events

More information

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Study Start-up

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

Jeri & Noboru Oishi Symposium

Jeri & Noboru Oishi Symposium Jeri & Noboru Oishi Symposium Using the NCI CIRB SWOG Fall Group Meeting Jeanne Hyatt M. Adler, Regency RN, in Chicago MPH, CCRP October 7-10, 2015 CTEP/DCTD/NCI9, 2013 AND LaTisa Hernandez, PA, CCRC,

More information

INVESTIGATOR HANDBOOK

INVESTIGATOR HANDBOOK INVESTIGATOR HANDBOOK Liberty IRB, Inc. 1450 S. Woodland Blvd., Suite 300A Deland, Florida 32720 Phone (386) 279-4318 Fax: (386)868-4563 Website: www.libertyirb.com Business hours: Monday Friday, 8:00am

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

Adverse Events in Clinical Trials: Definitions and Documentation

Adverse Events in Clinical Trials: Definitions and Documentation Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators Adverse Events in Clinical Trials: Definitions

More information

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Introduction The purpose of this module is to provide a basic understanding of the responsibilities of the principal

More information

GENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2):

GENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2): Make copies of the blank SAE report form as needed. Retain originals with confirmation of all information faxed to DMID Pharmacovigilance Group Clinical Research Operations and Management Support (CROMS

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

PHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE

PHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE PHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE PART A: TRIAL INFORMATION A1. Title of Clinical Trial (as stated in proposed Protocol) Protocol No.

More information

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES 1. Clinical Study Team Principal Investigator Co Principal Investigator (Co PI) Research Coordinator Study Monitor Data manage Sponsor Post Doctoral Scholar

More information

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

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

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

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

DATA AND SAFETY MONITORING PLAN

DATA AND SAFETY MONITORING PLAN Herbert Irving Comprehensive Cancer Center Columbia University Medical Center DATA AND SAFETY MONITORING PLAN Stephen G. Emerson, MD,PhD, Director Dawn Hershman, MD, MS, Associate Director of Clinical

More information

Vertex Investigator-Initiated Studies Program Overview

Vertex Investigator-Initiated Studies Program Overview Vertex Investigator-Initiated Studies Program Overview Our Goal To support independent, investigator-initiated research designed to advance scientific knowledge of disease states, patient populations,

More information

Investigational Drugs: Investigational Drugs and Biologics

Investigational Drugs: Investigational Drugs and Biologics : I. PURPOSE The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics to ensure that adequate safeguards are in place

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

Reliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s)

Reliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s) Name of Organization Providing IRB Review: Stony Brook University ( SBU IRB ) Name of Institution Relying on the SBU IRB ( Institution ): Latest AAHRPP Accreditation Date (if applicable) OHRP Federal Wide

More information

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB)

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB) March 1, 2006 M E M O R A N D U M F O R R E C O R D TO: FROM: SUBJECT: Deans Department Chairs Principal Investigators Brian Herman, Ph.D. Vice President for Research Investigator responsibilities for

More information

Introduction to Data Auditing

Introduction to Data Auditing How did we get here?? Introduction to Data Auditing David Hurd, M.D. Interim Chair, Data Audit Committee Wake Forest University School of Medicine CALGB Audit Preparation Workshop, June 2007 National Cancer

More information

Pre-Questions. Mastering Clinical Research July 29, 2015

Pre-Questions. Mastering Clinical Research July 29, 2015 Pre-Questions Mastering Clinical Research July 29, 2015 1. To be compliant with SOP 2.1 Obtaining Informed Consent for greater than minimal risk interventional clinical trial, which Licensed Professional

More information

Guidance for IRBs, Clinical Investigators, and Sponsors. Considerations When Transferring Clinical Investigation Oversight to Another IRB

Guidance for IRBs, Clinical Investigators, and Sponsors. Considerations When Transferring Clinical Investigation Oversight to Another IRB Guidance for IRBs, Clinical Investigators, and Sponsors Considerations When Transferring Clinical Investigation Oversight to Another IRB U.S. Department of Health and Human Services Food and Drug Administration

More information

Guidance for IRBs, Clinical Investigators, and Sponsors

Guidance for IRBs, Clinical Investigators, and Sponsors Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval U.S. Department of Health and Human Services Food and Drug Administration Center for

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

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

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

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

INSTITUTIONAL COMPLIANCE PLAN

INSTITUTIONAL COMPLIANCE PLAN INSTITUTIONAL COMPLIANCE PLAN Responsible Party: Board of Trustees Contact: Institutional Compliance Office Original Effective Date: 02/16/2012 Last Revised Date: 10/13/2014 Contents I. SCOPE OF THE PLAN...

More information

Health Products and Food Branch. www.hc-sc.gc.ca

Health Products and Food Branch. www.hc-sc.gc.ca Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration

More information

Nova Southeastern University Institutional Review Board Policies and Procedures

Nova Southeastern University Institutional Review Board Policies and Procedures Nova Southeastern University Institutional Review Board Policies and Procedures Monitoring of Approved Research, Approval Duration, and Continuing Review Effective 03/08/2007; Revised 10/14/2010; 8/29/2011;

More information

THE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum

THE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum THE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum 1. The object of this Bill is to provide the legal framework for the conduct of clinical trials for the purpose of discovering or verifying

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

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

Evaluation Instrument for Accreditation January 1, 2015

Evaluation Instrument for Accreditation January 1, 2015 Evaluation Instrument for Accreditation January 1, 2015 Copyright 2002-2014 AAHRPP. All rights reserved. Use of the Evaluation Instrument for Accreditation The Evaluation Instrument for Accreditation is

More information

Clinical Trials Reporting Program (CTRP) and Clinicaltrials.gov (CT.gov) Helpful tips and guidance

Clinical Trials Reporting Program (CTRP) and Clinicaltrials.gov (CT.gov) Helpful tips and guidance Clinical Trials Reporting Program (CTRP) and Clinicaltrials.gov (CT.gov) Helpful tips and guidance Objectives NCI s Clinical Trials Reporting Program (CTRP) Overview CTRP What is it? CTRP is an NCI mandated

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

Page 191 TITLE 21 FOOD AND DRUGS 355 1

Page 191 TITLE 21 FOOD AND DRUGS 355 1 Page 191 TITLE 21 FOOD AND DRUGS 355 1 APPEALS TAKEN PRIOR TO OCTOBER 10, 1962 Section 104(d)(3) of Pub. L. 87 781 made amendments to subsec. (h) of this section inapplicable to any appeal taken prior

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

Determining who the investigators are and who the principal investigator is:

Determining who the investigators are and who the principal investigator is: Responsibilities of the IRBs of the Health System and University for Research Conducted by Investigators from a Combination of the Following Institutions: the Health System, University, and Medical School

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

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

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

POLICY. Title: NIAID POLICY ON DATA AND SAFETY MONITORING BOARD (DSMB) OPERATIONS

POLICY. Title: NIAID POLICY ON DATA AND SAFETY MONITORING BOARD (DSMB) OPERATIONS POLICY Date: September 4, 2014 NIAID Bethesda, MD USA Page 1 of 11 Release Date: October 14, 2014 Effective Date: December 11, 2014 Title: NIAID POLICY ON DATA AND SAFETY MONITORING BOARD (DSMB) APPROVAL

More information

Clinical Trials and Safety Surveillance of Drugs in Development

Clinical Trials and Safety Surveillance of Drugs in Development Clinical Trials and Safety Surveillance of Drugs in Development Hoda Eid, M.Sc., Ph.D. Manager, ADR Unit Office of Clinical Trials Therapeutic Products Directorate hoda_eid@hc-sc.gc.ca Overview Clinical

More information

Nova Southeastern University Institutional Review Board Policies and Procedures

Nova Southeastern University Institutional Review Board Policies and Procedures Page 1 of 14 Purpose: To establish policy with respect to the emergency use of unapproved drugs and biologics. Definitions: 1. IRB approval means the determination of the IRB that the research has been

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

Prepared by: Clinical Trials Monitoring Branch Cancer Therapy Evaluation Branch Division of Cancer Treatment and Diagnosis National Cancer Institute

Prepared by: Clinical Trials Monitoring Branch Cancer Therapy Evaluation Branch Division of Cancer Treatment and Diagnosis National Cancer Institute NCI GUIDELINES FOR AUDITING CLINICAL TRIALS FOR THE NCI NATIONAL CLINICAL TRIALS NETWORK (NCTN) PROGRAM, COMMUNITY CLINICAL ONCOLOGY PROGRAM (CCOP) / NCI COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP) AND

More information

OPERATING PROCEDURES

OPERATING PROCEDURES OPERATING PROCEDURES CATEGORY: RESEARCH AFFAIRS CODE: H-27A APPROVED: 8/17/2010 SUBJECT: PROCEDURES FOR CONDUCT OF CONVENED IMPLEMENTED: 11/2010 REPLACES: PAGE: 1 of 6 Please note: Definitions are found

More information

CHARTER OF THE AUDIT AND RISK MANAGEMENT COMMITTEE OF THE BOARD OF DIRECTORS OF BLACKBERRY LIMITED AS ADOPTED BY THE BOARD ON MARCH 27, 2014

CHARTER OF THE AUDIT AND RISK MANAGEMENT COMMITTEE OF THE BOARD OF DIRECTORS OF BLACKBERRY LIMITED AS ADOPTED BY THE BOARD ON MARCH 27, 2014 CHARTER OF THE AUDIT AND RISK MANAGEMENT COMMITTEE OF THE BOARD OF DIRECTORS OF BLACKBERRY LIMITED AS ADOPTED BY THE BOARD ON MARCH 27, 2014 1. AUTHORITY The Audit and Risk Management Committee (the "Committee")

More information

Rev. 08/2008. Rebecca and John Moores UCSD Cancer Center CLINICAL RESEARCH POLICIES AND PROCEDURES (2008)

Rev. 08/2008. Rebecca and John Moores UCSD Cancer Center CLINICAL RESEARCH POLICIES AND PROCEDURES (2008) Rev. 08/2008 Rebecca and John Moores UCSD Cancer Center CLINICAL RESEARCH POLICIES AND PROCEDURES (2008) MOORES UCSD CANCER CENTER CLINICAL RESEARCH POLICIES TABLE OF CONTENTS Page I. INTRODUCTION 4 Clinical

More information

Essential Standard Operating Procedures Sample Templates Table of Contents

Essential Standard Operating Procedures Sample Templates Table of Contents Essential Standard Operating Procedures Sample Templates Table of Contents Introduction Study Conduct and Good Clinical Practice 1: JHM Training/Certification Documentation 2: Delegation of Responsibility

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

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

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 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

More information

NIH POLICY MANUAL. 1340 - NIH Occupational Safety and Health Management Issuing Office: ORS/DOHS 301-496-2960 Release Date: 2/27/06

NIH POLICY MANUAL. 1340 - NIH Occupational Safety and Health Management Issuing Office: ORS/DOHS 301-496-2960 Release Date: 2/27/06 NIH POLICY MANUAL 1340 - NIH Occupational Safety and Health Management Issuing Office: ORS/DOHS 301-496-2960 Release Date: 2/27/06 1. Explanation of Material Transmitted: This chapter establishes the scope

More information

Application Guide. 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research

Application Guide. 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research Application Guide 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research A Competitive Grants Program Supported by Pfizer www.aspireresearch.org Table of Contents THE ASPIRE

More information

Compliance Programs in Academic Medical Centers. Georgetown University

Compliance Programs in Academic Medical Centers. Georgetown University Compliance Programs in Academic Medical Centers Kenneth L. Dretchen, PhD Director of Regulatory Affair Chair, Department of Pharmacology Sheila Cohen Zimmet, RN, JD Director, Research Assurance and Compliance

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

Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions

Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions U.S. Department of Health and Human Services Food and Drug Administration Center for

More information

Clinical Trial Protocol Development. Developed by Center for Cancer Research, National Cancer Institute Endorsed by the CTN SIG Leadership Group

Clinical Trial Protocol Development. Developed by Center for Cancer Research, National Cancer Institute Endorsed by the CTN SIG Leadership Group Clinical Trial Protocol Development Developed by Center for Cancer Research, National Cancer Institute Endorsed by the CTN SIG Leadership Group Objectives The clinical trial protocol is the heart of any

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

Medical College of Georgia SOP NUMBER: 03 INVESTIGATIONAL DRUG HANDLING Version Number: 1.0, 1.1 Effective Date: 09/12/06, 08/02/10, 3/2/11

Medical College of Georgia SOP NUMBER: 03 INVESTIGATIONAL DRUG HANDLING Version Number: 1.0, 1.1 Effective Date: 09/12/06, 08/02/10, 3/2/11 Effective Date: 09/12/06, 08/02/10, 3/2/11 Title: 1.0 OBJECTIVE: 1.1 This SOP describes the methods and policies for: Handling investigational drug Dispensing investigational drug 1.2. This procedure applies

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Cancer Drug and Biological Products Clinical Data in Marketing Applications U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and

More information

Adventist HealthCare, Inc.

Adventist HealthCare, Inc. IRB POLICY ON HUMAN RESEARCH PROTECTION (HRP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING Collaborative Institutional Training Initiative (CITI) Requirements at Adventist Healthcare, Inc. I. Required Human

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

Winthrop University Hospital Research Financial Interests Disclosure Policy

Winthrop University Hospital Research Financial Interests Disclosure Policy This policy sets forth Winthrop-University Hospital s (WUH) requirements and guidelines for disclosing applicable Research Financial Interests. It includes: I. Definitions of Key Terms II. Policy and Procedures

More information

Monitoring & Auditing of Clinical Trials. Sponsored by Center for Cancer Research National Cancer Institute

Monitoring & Auditing of Clinical Trials. Sponsored by Center for Cancer Research National Cancer Institute Monitoring & Auditing of Clinical Trials Sponsored by Center for Cancer Research National Cancer Institute Objectives Guidelines suggest that following the good clinical research practice of monitoring/auditing

More information

This policy applies to research administrators, investigators, research staff, Human Investigation Committee (HIC) members and HIC staff.

This policy applies to research administrators, investigators, research staff, Human Investigation Committee (HIC) members and HIC staff. REVIEW BY AN EXTERNAL INSTITUTIONAL REVIEW BOARD 233 1 of 5 PURPOSE The purpose of this policy is to establish a procedure for requesting authorization for an approved, external (non-beaumont) institutional

More information

Medical Billing Human Research Studies Seminar Notes

Medical Billing Human Research Studies Seminar Notes Audits If a department learns that an external audit is going to be initiated, the Billing Compliance Department and Research Administration should be notified when the scope of the audit involves billing

More information

The Ontario Cancer Research Ethics Board Overview

The Ontario Cancer Research Ethics Board Overview The Ontario Cancer Research Ethics Board Overview Research Ethics Research ethics review is vital to the advancement of ethically sound research. Before individuals can be enrolled in a research study,

More information

STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE

STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE UNC OB/GYN (V.1) 9.1.2014 Page i TABLE OF CONTENTS INTRODUCTION. iii ABBREVIATIONS iv GLOSSARY v LISTING OF ATTACHMENTS.... xi I. 1.0 GENERAL ADMINISTRATION

More information

RULES OF DEPARTMENT OF HEALTH DIVISION OF PAIN MANAGEMENT CLINICS CHAPTER 1200-34-01 PAIN MANAGEMENT CLINICS TABLE OF CONTENTS

RULES OF DEPARTMENT OF HEALTH DIVISION OF PAIN MANAGEMENT CLINICS CHAPTER 1200-34-01 PAIN MANAGEMENT CLINICS TABLE OF CONTENTS RULES OF DEPARTMENT OF HEALTH DIVISION OF PAIN MANAGEMENT CLINICS CHAPTER 1200-34-01 PAIN MANAGEMENT CLINICS TABLE OF CONTENTS 1200-34-01-.01 Purpose 1200-34-01-.06 Notifications 1200-34-01-.02 Definitions

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

How To Be A Successful University

How To Be A Successful University TUSDM Patient Billing and HIPAA Privacy Compliance Program Adopted: 12/14/12 TABLE OF CONTENTS Section 1. Definitions 2. Objectives Page 1 1 3. Oversight Responsibility 2 4. Compliance Procedures for Submitting

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

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

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

COUPONS.COM INCORPORATED CHARTER OF THE AUDIT COMMITTEE OF THE BOARD OF DIRECTORS

COUPONS.COM INCORPORATED CHARTER OF THE AUDIT COMMITTEE OF THE BOARD OF DIRECTORS COUPONS.COM INCORPORATED CHARTER OF THE AUDIT COMMITTEE OF THE BOARD OF DIRECTORS I. STATEMENT OF POLICY This Charter specifies the authority and scope of the responsibilities of the Audit Committee (the

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

Final. National Health Care Billing Audit Guidelines. as amended by. The American Association of Medical Audit Specialists (AAMAS)

Final. National Health Care Billing Audit Guidelines. as amended by. The American Association of Medical Audit Specialists (AAMAS) Final National Health Care Billing Audit Guidelines as amended by The American Association of Medical Audit Specialists (AAMAS) May 1, 2009 Preface Billing audits serve as a check and balance to help ensure

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

Clinical Research Professional Certification & Preparing for the CCRP Exam

Clinical Research Professional Certification & Preparing for the CCRP Exam Clinical Research Professional Certification & Preparing for the CCRP Exam Signe Denmark, MS, CCRP Toni Mauney, CCRP SoCRA: Society of Clinical Research Associates SoCRA established the Certification Program

More information

The University of Texas Health Science Center at Houston Institutional Healthcare Billing Compliance Plan JANUARY 14, 2013

The University of Texas Health Science Center at Houston Institutional Healthcare Billing Compliance Plan JANUARY 14, 2013 JANUARY 14, 2013 I. Preamble The University of Texas Health Science Center at Houston (UTHealth) is committed to ensuring that its affairs are conducted in accordance with applicable laws and regulations.

More information

CTEP Workshop. An Overview of the NCI s Cancer Therapy and Evaluation Program (CTEP) CTEP s Mission. Workshop Objectives. NCI Organizational Structure

CTEP Workshop. An Overview of the NCI s Cancer Therapy and Evaluation Program (CTEP) CTEP s Mission. Workshop Objectives. NCI Organizational Structure CTEP Workshop Elizabeth Ness, RN, MS Director, Staff Development Center for Cancer Research National Cancer Institute Workshop Objectives At the end of this workshop, participants will be able to: Discuss

More information

Evaluation Instrument for Accreditation January 1, 2016

Evaluation Instrument for Accreditation January 1, 2016 Evaluation Instrument for Accreditation January 1, 2016 Copyright 2002-2014 AAHRPP. All rights reserved. Use of the Evaluation Instrument for Accreditation The Evaluation Instrument for Accreditation is

More information

and Regulatory Aspects

and Regulatory Aspects Good Clinical Practice and Regulatory Aspects Nora Espiritu MD, MPh, PhD (c) Former Executive Director of Research and Technology Transfer. Peruvian National Institute t of Health. Member of the Ethics

More information

Administrative Procedure Chapter 12, Research Administrative Procedure: AP 12.217, Procedure for Institutional Oversight of Life

Administrative Procedure Chapter 12, Research Administrative Procedure: AP 12.217, Procedure for Institutional Oversight of Life Administrative Procedure, AP 12.217 Procedure for Institutional Oversight of Life Sciences Dual Use Research of Concern Page 1 of 15 Administrative Procedure Chapter 12, Research Administrative Procedure:

More information

EXHIBIT COORDINATING PROVISIONS-STATE/FEDERAL LAW, ACCREDITATION STANDARDS AND GEOGRAPHIC EXCEPTIONS MARYLAND

EXHIBIT COORDINATING PROVISIONS-STATE/FEDERAL LAW, ACCREDITATION STANDARDS AND GEOGRAPHIC EXCEPTIONS MARYLAND EXHIBIT COORDINATING PROVISIONS-STATE/FEDERAL LAW, ACCREDITATION STANDARDS AND GEOGRAPHIC EXCEPTIONS MARYLAND I. INTRODUCTION: Scope. To the extent of any conflict between the Agreement and this State

More information