CLINICAL TRIAL FEASIBILITY AND CAPACITY PLANNING FORM

Transcription

1 1 CLINICAL TRIAL FEASIBILITY AND CAPACITY PLANNING FORM Clinical trials that run into difficulties often have problems that could have been spotted in advance. An early feasibility assessment helps determine whether recruitment to a clinical study is likely to be completed successfully, taking into account the practical aspects of trial conduct and the resources required.

2 2 FEASIBILITY AND CAPACITY PLANNING FORM PURPOSE Part 1: Investigator s Feasibility Analysis (Projected Recruitment and Resources): A robust feasibility analysis will help answer the question; How many patients can we recruit to this study within the timeframe available? For internally sponsored (e.g. investigator-initiated) clinical trials, the investigator should consider each question in Part 1 of this form to accurately determine a projected recruitment target based on patient population, and the staff and resources needed to complete the required procedures. For externally sponsored trials, if the site is completing a similar feasibility form for the sponsor during the site selection process, this document may be adapted accordingly, and/or may be used to document an internal assessment to inform the responses provided to the sponsor. Part 2: Capacity Planning Exercise: The investigator/research team should complete Part 2 of the form highlighting, for each service department, the total number of tests/assessments required together with any protocol-specific activity that is over and above standard care. The completed form (together with the protocol/synopsis containing the schedule of assessments) will be forwarded to all relevant service departments to allow an assessment of impact on resources (time/staff/facilities). The objective of this assessment will be to: 1. Initiate early contact with all relevant 1 service departments so that each department can review the trial s requirements and confirm its ability to support the trial from a capacity and resource standpoint. 2. Identify any protocol-specific tests/assessments that cannot be serviced internally so that negotiations with third party providers can be begin early in the approvals process. 3. Provide an early indicator for any potential problems with study set up or delivery. It is recommended that departments are given a maximum of 10 working days from the date the completed form is sent, to review the form and to feedback any comments or concerns to the research team unless the investigator feels that additional review time is required. The closing date for review should be entered at the end of this document. HOW CAN REVIEWERS FEEDBACK COMMENTS/CONCERNS? Section 16 of this form can be used to make notes and comments to be sent back to the trials team. IF YOU HAVE ANY QUESTIONS REGARDING THIS FORM PLEASE CONTACT: Phone: Research Office XXXXX 1 Only departments that will be required to perform tests/activities over and above standard care will be contacted.

3 3 PART 1: Confirmation of Projected Recruitment 1. GENERAL INFORMATION Full Study Title and Trial Number: Sponsor: Department undertaking trial: HREC Submission Date: Date of Site Selection Visit (if any): Principal Investigator at Site: Assigned lead Trial Coordinator: Sponsor/CRO Contact Details: Name: Name: Name: Sponsor s preferred start date: HREC Approval Date (if applicable): Sponsors Preferred Trial Start Date: Contact Details Contact Details Contact Details 2. PROJECTED RECRUITMENT (ICH GCP 4.2.1) Would any of the following factors make it difficult to identify suitable patients? Inclusion/exclusion criteria Disallowed concomitant medications or procedures Visit schedule/duration Please specify: Other medical conditions Drug formulation/route of administration Wash-out period Other Are there any current or planned competing studies at the site? Is there another option available for obtaining the intervention/treatment that may hinder recruitment, such as registered or off-label use of a similar intervention? Is the trial open to competitive recruitment (all other sites allowed to over recruit)? Projected end of recruitment (confirmed by sponsor) What is the source of patients and how will they be identified (clinic, outpatients, inpatient)?

4 4 Based on past/current knowledge and record review: Patients eligible for the study per month/week? (circle one) Percentage of eligible patients that is likely to enroll in the study? Estimated total recruitment for the study duration? 3. INVESTIGATOR TEAM RESOURCES (STAFF/EQUIPMENT/TIME) (ICH GCP 4.1.1, and 4.2.3) Investigators previous clinical trial experience: Please provide a brief summary to support this role. Coordinators previous clinical trial experience. Please provide a brief summary to support this role. Clinical Time: Can the investigator/clinical team accommodate study visits and procedures? If, please comment on additional resources required. Data-management: Can the clinical team accommodate the CRF and source document completion, query resolution, monitoring visits, and other administrative requirements? If, please comment Are there adequate staff resources including the requirement for any specialised staff to meet study requirements (e.g. technicians, physical therapists) If, please comment Does the site have all the equipment needed to complete the study (fridges, freezers, adequate space for secure record storage, non-standard equipment) If, please comment Will all staff have the necessary training (e.g. GCP training) before study start? If, GCP training will be required for all staff involved in the trial. Will this site take the role of lead site? If YES, please confirm whether the CPI has adequate administrative resources to perform additional lead site duties, such as forwarding submission correspondence between the sponsor and the HREC.

5 5 PART 2 To be completed by the Investigator/research team and sent electronically for review to all relevant departments (List in Section 17) Please reference the page of the attached protocol for the specific Schedule of Assessments Please confirm to each department, the estimated total recruitment figure derived from Part 1 of this form or from an equivalent external sponsor's feasibility assessment. Circle N/A for any sections which are non-applicable) 4. PHARMACY N/A DRUG ADMINISTRATION N/A Is it anticipated that treatment will be given as an inpatient? Is it anticipated that treatment will be given on Medical Day Unit (MDU)? if yes please answer questions below Where will treatment be given if not MDU? On which MDU will treatment be given? if other please state location: What is the expected length of time a patient will be on MDU per treatment? Will there be a requirement to store therapeutic goods in a location other than pharmacy? If so, please describe the arrangements. Including prep time, other treatments, administration, observations etc. PLEASE NOTE: If patients are being treated on the MDU please include 30 minutes pre and 30 minutes post treatment as standard. E.g. Large device boxes, out of hours delivery of drug. 5. OUTPATIENTS VISITS excluding delivery of treatment. Refer to attached study visit schedule. N/A Total. of Outpatient Visits. standard. research Estimated duration of visits (or of each visit?) Location Additional comments:

6 6 6. HISTOPATHOLOGY / TISSUE COLLECTION N/A Refer to attached study visit schedule. Archived Tissue Sample to be collected by Total Required NO. STANDARD NO. RESEARCH Please State Any Processing or Analysis Required at XX Are to be Sent to an External Institution? External Institution details (if known) Fresh Tissue Is there a possibility that those collecting tissue samples will work outside of normal hours? 7. LABORATORY PROCESSING/ANALYSIS/EVALUATION N/A Refer to attached study visit schedule. Excluding samples for PK, PD and translational research. Please List Below Laboratory Tests Additional to Standard Care e.g. conjugated bilirubin, urinalysis Further detail can be found in the schedule of assessments RE: frequency etc : Please State Any Processing or Analysis Required at XXX Are to be Sent to an External Institution? External Institution details (if known) Is there a possibility that those collecting tissue samples will work outside of normal hours? 8. LABORATORY SAMPLES FOR TRANSLATIONAL RESEARCH N/A e.g. blood, ascites, urine etc. Refer to attached study visit schedule. of Required NO. STANDARD NO. RESEARCH Blood Urine Stool Saliva Ascites Bone Marrow Other Is there a possibility that those collecting samples will work outside of normal hours? Please State Any Processing Required at XXX e.g. centrifuge, temperature control Are to be Sent to an External Institution? External Institution details (if known)

7 7 9. PHARMACOKINETIC AND PHARMACODYNAMIC (PK & PD) SAMPLES N/A Refer to attached study visit schedule. of Required Please State Any Processing Required at XXX? e.g. centrifuge Are to be Sent to an External Institution? PK PD Is there a possibility that those collecting samples will work outside of normal hours? External Institution details (if known) 10. IMAGING GUIDED BIOPSIES N/A Refer to attached study visit schedule. Which Imaging Modality is Required? (where protocol allows for more than one possible modality please state all possibilities) If other is selected, please provide details: Total. of Biopsies:. Considered Standard:. Considered Research: 11. IMAGING further detail can be found in the schedule of assessments RE: frequency etc N/A Refer to attached study visit schedule. INVESTIGATIONS Contrast Enhanced CT BODY AREA TOTAL NO. SCANS NO. STANDARD NO. RESEARCH CT MRI DCE-CT / CT Perfusion GA appointments required? (paediatrics) Functional MRI DCE-MRI DW-MRI Whole Body DWI MRS (Spectroscopy) GA appointments required? (paediatrics)

8 8 MUGA FDG PET CT Choline PET-CT Radioisotope GFR Nuclear Medicine Bone Scan MIBG Scan DEXA Scan GA appointments required? (paediatrics) Standard Dynamic Contrast U/S Ultrasound (DCE) GA appointments required? (paediatrics) Plain film Fluoroscopy Interventional Procedure X-Ray please state (exc. biopsies): GA appointments required? (paediatrics) Are scans required to be uploaded for central review? Are scans to be reported using a specific system? Please specify the reporting system required: if other is selected please provide details If RECIST measurements are required who will be responsible for carrying out the measurements? 12. ECHOCARDIOGRAMS AT THE XXX N/A where investigations are required external to XXX please see overleaf. Refer to attached study visit schedule. Echocardiogram Total. of scans. standard. research Location 13. RADIOTHERAPY N/A further detail can be found in the schedule of assessments RE: frequency etc. Refer to attached study visit schedule. For studies involving radiotherapy, the radiotherapy team will extract the relevant information from this form and the protocol.

9 9 14. OTHER INVESTIGATIONS - Please list below any other investigations or visits required either at the XXX or from an external provider i.e. Ophthalmology, ECG, hearing tests, administration of participant surveys/or questionnaires. Refer to attached study visit schedule. Investigations Location Total.. standard. research Is a Service Level Agreement Required? 15. FACILITIES AND EQUIPMENT Please list below any required equipment and whether it is available for use for this study. Facilities/equipment Available? 24/7 temperature monitored? Back-up power source? -70 degree refrigerator / / / N/A / / N/A Refrigerated centrifuge / / / N/A / / N/A ECG Machine / / / N/A / / N/A Weighing scales / / / N/A / / N/A Peak flow machine / / / N/A / / N/A Temperature Loggers / / / N/A / / N/A Other (add rows as needed): / / / N/A / / N/A 16. FREE TEXT FOR ANY COMMENTS OR CONCERNS REGARDING RESOURCES AND CAPACITY TO SUPPORT THIS STUDY Reviewer's Name: Department: Comments:

10 CAPACITY FORM DISTRIBUTION LIST Please check the appropriate individuals to review this form. Responsibility lies with the PI and Clinical Unit for ensuring that the correct personnel receive this form. R&D DEPARTMENT CONTACT NOTES Research Office Team Always Check Box Pharmacy Trials with a medicinal product Radiology / Imaging Radiopharmacy MRI / Ultrasound Radiotherapy review / capacity If clinical trial involves any of the following, MUGA, FDG PET CT, Choline PET CT, radioisotope GFR, bone scan, MIBG scan, other. Or if an ARSAC is required Trials requiring MRI/ultrasound investigations Trials involving radiotherapy Finance Laboratories Tissue Trials requiring archived tissue either at RM or external Trusts Service Managers Admissions and Preassessment Unit (APU) Trials requiring ECHOs to be carried out in XX Date ed to the support departments: Closing date for review and return of comments (10 working days from above date):