External Performance Site Assessment Committee Feasibility Checklist
Cancer Consortium Protocol #:
Title of Protocol:
Name of Cancer Consortium Study PI: Name of the Cancer Consortium IND/IDE Sponsor:
Name of the External Investigator:
Location of External Investigator (Name of Institution, Clinic, etc.)
This form will be used by the External Performance Site Assessment Committee (EPSAC) to verify Cancer Consortium investigator compliance with 21 CFR 312.50; verify external investigator capacity to comply with 21 CRF 312.50; and to provide institutional risk assessment for Cancer Consortium investigator-initiated, multi-center studies under an IND/IDE, for which a Cancer Consortium investigator is the IND/IDE sponsor. Notable Information: Additional documentation reviewed by EPSAC may include: a. Cancer Consortium Submission Checklist b. Study documents (Synopsis, Protocol, Consents, IB, IRB Application w/supplements, etc.)
Instructions for completion: Section A is to be completed by the external investigator (or designee). Section B is to be completed by the Cancer Consortium study Principal Investigator (or designee). Section C is to be completed by the Cancer Consortium IND/IDE sponsor. Signatures are required by the external investigator, Cancer Consortium study Principal Investigator, and Cancer Consortium IND/IDE sponsor (if different than the Cancer Consortium study PI). The Committee must review your new external investigator (and lead coordinator) prior to establishing the site agreement and before enrollment of participants by the external investigator can commence. A separate form must be completed for each external investigator.
Section A: To be completed by the External Investigator (or designee).
Questions 1-5 help indicate qualifications of the external investigator and lead coordinator “…by training or experience as appropriate experts to investigate the drug.” (21 CFR 312.50 and 312.53). 1. A copy of your current CV is attached for review by the External Performance Site Assessment Committee? Yes Pending 2. EPSAC requires GCP training for all external investigators engaged in research, when for the purposes of the research project, they are involved with obtaining informed consent, determining eligibility and/or administration of investigational product to the study participant. Accepted GCP courses include: CITI online course: Basic Course in Good Clinical Practice Good Clinical Practice Training offered by Institutes within the NIH Other equivalent GCP training provided by an industry sponsor or other organization may be accepted as determined by EPSAC. A copy of your completed a GCP training record is attached? Yes Pending
3. For clinical trial experience, please indicate the following: How many previous clinical trials have you had as a study PI? How many total patients have enrolled in clinical trials where you were the study PI? Please mark one: 0 patients <5 patients 5-15 patients >15 patients >25 patients 4. For IND/IDE experience, please indicate the following: Have you ever participated in a study under an IND/IDE? Yes No Have you ever participated in an investigator-initiated IND/IDE? Yes No
EPSA2400 External Performance Site Feasibility Checklist Page 1 of 5 Version: 02/02/2017 External Performance Site Assessment Committee Feasibility Checklist
Cancer Consortium Protocol #:
Title of Protocol:
Name of Cancer Consortium Study PI: Name of the Cancer Consortium IND/IDE Sponsor:
Name of the External Investigator:
Location of External Investigator (Name of Institution, Clinic, etc.)
Have you ever been the IND/IDE sponsor? Yes No Have you been inspected by the FDA? Yes No If yes, respond to the following: Was a 483 issued? Yes No Was a warning letter issued? Yes No If yes, what was the final outcome?
5. For research staff aiding in the conduct of this study, please indicate the following: A lead coordinator is defined as a research nurse or coordinator who evaluates lab results and completes case report forms for a clinical intervention or prevention trial testing the use of an FDA regulated drug, biologic, and/or device. Is there a lead coordinator dedicated to the study? Yes No* If yes, a copy of the current lead coordinator’s resume is attached for review by the External Performance Site Assessment Committee? Yes Pending EPSAC requires GCP training for lead coordinators, a copy of the lead coordinator’s completed GCP training record is attached? Yes Pending See Section A, question 2 for the list of accepted GCP courses. Is the lead coordinator qualified by clinical trial experience in the disease being studied in the protocol and therapeutic clinical trial training? Yes No Has your lead coordinator ever been involved with the conduct of an IND/IDE study? Yes No If yes, when was the last study he/she was involved with?
*If there is no lead coordinator for this study, please explain:
Questions 6-7 help indicate “…proper monitoring of the investigation.” (21 CFR 312.50) 6. Have you agreed to the planned frequency and extent of monitoring? Yes No 7. Is there an independent monitoring resource available at your location? Yes No Questions 8-12 help indicate “…that the investigation is conducted in accordance with the general investigational plan and protocol contained in the IND.” (21 CFR 312.50) 8. Have you worked with a Cancer Consortium PI or a Cancer Consortium sponsor investigator in the past 5 years? Yes No If yes, indicate the following: Did you have any problems meeting the enrollment goals? Yes No Did you have any problems with serious or continuing noncompliance? Yes No
EPSA2400 External Performance Site Feasibility Checklist Page 2 of 5 Version: 02/02/2017 External Performance Site Assessment Committee Feasibility Checklist
Cancer Consortium Protocol #:
Title of Protocol:
Name of Cancer Consortium Study PI: Name of the Cancer Consortium IND/IDE Sponsor:
Name of the External Investigator:
Location of External Investigator (Name of Institution, Clinic, etc.)
9. Does your site have an investigational pharmacy that will store/dispense investigational product? Yes No If no, will the investigational product be stored/dispensed by a pharmacy? Yes No If there is not a pharmacy or investigational product will not be stored/dispensed by the pharmacy: Where will the investigational product be stored? Who will maintain the inventory? 10. Are there other institutional entities that must review and/or approve the study in addition to the IRB (scientific review, feasibility assessment, etc.) at your location? Yes No If yes, list the entities reviewing the study.
11. Is the IRB at your location available to approve changes to the consent outside the annual renewal period? Yes No 12. Will the FHCRC/UW, FDA, IRB and NCI/NIH be listed on your consent form and be permitted access to study data? Yes No If no, please explain.
Section A: Signature by the external investigator As an external investigator supporting a Cancer Consortium investigator-initiated, multi-center study with an IND/IDE, for which a Cancer Consortium investigator is the IND/IDE sponsor, I acknowledge that the information provided is accurate and that committee approval must be secured before the external site agreement is finalized and before enrollment of participants begins. Print Name Signature Date Form Completed by: (if not the investigator)
External Investigator: Additional information may be requested by the Committee to complete the assessment.
EPSA2400 External Performance Site Feasibility Checklist Page 3 of 5 Version: 02/02/2017 External Performance Site Assessment Committee Feasibility Checklist
Cancer Consortium Protocol #:
Title of Protocol:
Name of Cancer Consortium Study PI: Name of the Cancer Consortium IND/IDE Sponsor:
Name of the External Investigator:
Location of External Investigator (Name of Institution, Clinic, etc.)
Section B: To be completed by the Cancer Consortium study Principal Investigator (or designee).
IND/IDE #:
Investigational Drug/Biologic Select type of product: Investigational Device Marketed Drug/Biologic under an IND
Provide a brief Description/Name of product
Questions 1-6 help indicate qualified investigators are provided “…information they need to conduct an investigation properly.” As well as to indicate “…the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigation and ensuring that FDA and all participating investigators are informed of significant new adverse effects or risks with respect to the drug.” (21 CFR 312.50) 1. Have the CRFs been developed? Yes No 2. Have the CRF instructions been developed? Yes No 3. Describe (or attach documents describing) how investigators and study staff at other sites will be trained for this clinical trial:
4. Describe (or attach documents describing) the data QA process in this trial.
5. Describe (or attach documents describing) the method for tracking trends in AEs, enrollment and stopping criteria.
6. Does the study include the use of a cellular or biological product? Yes No If yes, where will the product be manufactured for this external investigator? Indicate all locations.
Questions 7-9 help indicate “…proper monitoring of the investigation.” (21 CFR 312.50) 7. Describe (or attach documents describing) the plans for monitoring this clinical trial at external sites.
8. Will this external investigator receive funding to perform the study? Yes No
9. Who is funding the monitoring?
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Cancer Consortium Protocol #:
Title of Protocol:
Name of Cancer Consortium Study PI: Name of the Cancer Consortium IND/IDE Sponsor:
Name of the External Investigator:
Location of External Investigator (Name of Institution, Clinic, etc.)
Section B: Signature by the Cancer Consortium PI. As Principal Investigator of a Cancer Consortium investigator-initiated, multi-center study with an IND/IDE, for which a Cancer Consortium investigator is the IND/IDE sponsor, I acknowledge that all of the required documentation must be submitted and that committee approval must be secured before the external site agreement is finalized and before enrollment of participants begins. Print Name Signature Date
Form Completed by: (if not the PI)
Cancer Consortium Principal Investigator:
Section C: Signature by the Cancer Consortium IND/IDE Sponsor
As the Cancer Consortium IND/IDE sponsor, I acknowledge that all of the required documentation must be submitted and that committee approval must be secured before the external site agreement is finalized and before enrollment of participants begins. Print Name Signature Date
Cancer Consortium IND/IDE Sponsor:
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