CPN Regulatory Document Checklist
CPN Regulatory Document Checklist
√ / Documents that pertain to theentire institution / Why? That’s a good question.
Participating/Treating Site Application / This form gathers all of the information required to “define” the institution in the Mayo Clinic Cancer Center MCCC database. If the institution is already defined in the database, then this form should be reviewed for accuracy.
Receipt of Study Agents / Pharmacy contact information is gathered and entered into the MCCC database for audit purposes and for distributing ordered study agent (when the MCCC research pharmacy is involved). If the pharmacy is already defined in the database, please review for accuracy.
FWA Assurance / Documentation that your institution is currently in compliance with Federal regulations regarding conduct of clinical trials and protection of clinical trial subjects.
IRB (or any Review of Ethics Board) Registration / Many institutions have more than one IRB committee. This documents the fact that a specific IRB committee operates under an institution’s FWA.
Lab Certifications (i.e. CAP and CLIA) / Federal Regulation: If any clinical lab tests are required by a specific protocol, they must be performed by a certified clinical lab.
Lab normal values and reference ranges / If the results of any clinical lab tests are required for (1) eligibility or (2) monitoring of safety and toxicity, the normal values/reference ranges must be on file and available for review by a monitor or auditor. This is to confirm eligibility or compliance with AE reporting requirements.
- For more information: Section 8.2.11).
√ / Documents that pertain to
a specific clinical trial / Why? Sometimes we also wonder about that.
Study-specific 1572 / This form provides a summary of all the components required for the conduct of the clinical trial. Many of the other required documents support the Boards, Labs, Investigators, and study team members listed on this form.
See Note #3 for the list of individuals to list in Fields #1 and #6.
Documentation of Initial IRB/REB Approval (and annual continuing review/approval) / Documentation that an official, registered Institutional Review Board/Ethics Committee has reviewed the study to confirm the fact that all study participants will be treated with respect, justice, and beneficence, as required by Federal Regulation, 45 CFR 46.
Documentation that the site Principal Investigator for the study has received the current Investigator Brochure (IB) or Package Insert, if applicable / The IB is the published statement of the risks associated with the use of an investigative agent or an FDA-approved agent being used for a reason other than that for which it was approved. The site PI must be aware of this “risk profile” in order to approve the risk language in the informed consent document.
IRB-approved informed consent document (and all subsequent versions of the consent form) / Each IRB/REB must review the informed consent document to make sure all of the components of informed consent are available. There should be dates on the informed consent document specifying when it was approved and when it will expire so that a monitor/auditor can confirm each study participant signed the correct form.
Recruitment, Retention, and Adherence Plan / This plan documents the fact that the site personnel have reviewed available resources and developed a plan for recruiting participants in a timely manner.
Delegation of Tasks (DOT) Form / Some study sponsors use a Delegation of Authority form. DCP believe that the site PI cannot delegate authority for a task. He/she is still responsible. However, the PI can delegate tasks. All individuals involved in the conduct of a clinical trial should be listed on this form along with the specific tasks that are allowed to do. All investigators, sub-investigators, study coordinators, data entry personnel, regulatory specialists, pharmacy personnel, and primary back-up personnel should be listed on this form. This form also collects for comparison the signatures and initials that will be acceptable on eligibility checklists, revised case report forms, and submitted regulatory documents. See footnote #3.
- Any document with an expiration date on it, such as FWA, Consent form, CAP certificate, etc., must be current and kept up-to-date in real time for continued participating in the clinical trial. Please submit new/revised documents immediately.
- On the study-specific 1572, the site PI should be listed in Field #1. He/she has full responsibility for all aspects of the conduct of this clinical trial at the institution listed in Field #3 and should be encouraged to read the fine print on the second page of the form.
- In Field #6, list all sub investigators, study coordinators, and data entry personnel who consent participants, conduct study visits, collect participant data, and/or enter data onto CRFs (electronic or paper). If pharmacy personnel visit directly with the participants to discuss anything about the study agent (instructions for taking the agent, side effects, etc.) they should be listed. If the pharmacy personnel simply dispense the study agent, they do not have to be listed.
- Note: For each person on the DOT form, documentation of Good Clinical Practice (GCP) training is also required. The Collaborative Institutional Training Initiative (CITI) GCP program is an acceptable option:
Keep going→
√ / For each person who will register participants via the CPN Registration Office and/or will need access to the password-protected portion of the CPN website / CPN Roster Form / CPN Affirmation of Integrity Form (AOI) / CPN Conflict of Interest Disclosure Form (COI) / GCP training / CV and Medical License / DCP, FDF / CTEP 1572 / CTEPFDF / CTEP Investigator Data Form
Why? We hope these explanations make sense. / The purpose of these six documents is to gather the information required to define each individual in the MCCC database. All forms must be reviewed and updated, if necessary, on an annual basis. They do not need to be resubmitted for a new clinical trial if the information in the database is already up-to-date. / This is an NCI, DCP requirement for everyone on the study-specific 1572. / All investigators who register participants to CPN Clinical trials and/or receive NCI funding for the conduct of a clinical trial must have an NCI Investigator Code. See footnote #5 below for more information.
Site PI / X / X / X / X / X / X / X / X / X
Study Coordinator / X / X / X / X / X / X
Data Entry Coordinator / X / X / X / X / X / X
Sub investigator / X / X / X / X / X / X / X / X / X
Sub investigator / X / X / X / X / X / X / X / X / X
Sub investigator / X / X / X / X / X / X / X / X / X
Pharmacist / X / X / X / X
Enter your site’s personnel here. Add more lines if needed.
- NCI, Cancer Therapy Evaluation Program (CTEP) has responsibility for registering and confirming on-going licensure and qualifications for all investigators who receive NCI funding for the conduct of clinical trials. This was originally put in place to monitor distribution of study agent, but its function now covers all individuals who receive NCI funding. By being awarded a subcontract for the conduct of a CPN-sponsored clinical trial, the investigator is technically receiving NCI funding. The original copies of the three CTEP forms along with copies of the CV (signed and dated within the previous 12 months) and current medical license will be submitted on behalf of the investigator by the CPN Operations Office. If an investigator already has an NCI Investigator Code, these forms do not need to be submitted. If in doubt, check with the CPN Operations Office. Please note, we have been told that this will eventually apply to study coordinators as well. For now, it’s just the investigators.
1
Reg Doc Checklist 2014