Each clinical trial proposal must pass through a series of reviews before it is approved to be opened for recruiting.
First, a full study protocol undergoes Primary Department Review by the primary department of the Primary Investigator (PI), and by the secondary department if there is a Co-PI in a secondary department. The protocol documents are sent by the sponsor to the individual MSK study team managing the protocol. MSK’s review process begins on the date that the full protocol package (documents listed below) is reviewed at the first committee meeting (Departmental Review).
The protocol documents required for submission for Primary Department Review are as follows:
- Final and current protocol (draft protocols are not allowed)
- Appendices (if applicable)
- Drug diary (if applicable)
- Questionnaires (if applicable)
- Investigator’s Brochure(s) (if applicable)
Protocol Manuals (if applicable: drafts are accepted if the study is industry-funded)
- Laboratory Manual
- Imaging Manual
- Pharmacy manuals
- EKG manuals
- Protocol Face Sheet
- Materials for patients
- External budget template and sponsor contact information (if industry-funded)
The Research Council reviews study proposals for scientific merit and priority before submission to the Institutional Review Board (IRB) as well as existing studies for progress. The Research Council is comprised of two groups that meet bi-weekly on alternate weeks. Submissions must be received nine days before the meeting date.
The study team, led by the Clinical Research Manager (CRM), works with the sponsor to obtain the regulatory documents. Along with managing the regulatory document collection, the study team prepares the protocol documents and submits them to the Protocol Activation Core (PAC), the centralized group who coordinates the protocol submission activities. Submission timelines to PAC are dictated by PI and service priorities. Once submitted to PAC, each protocol is assigned a Protocol Activation Manager (PAM), who acts as the main point of contact throughout the submission process, including the management of the informed consent language negotiations.
The next step is Site Selection and Initiation Visits (SSVs, SIVs) which are coordinated by the protocol study team. All investigators, pharmacy, research nurses, research sample management team, and study teams are invited to the SIV. The purpose of the visit is to ensure the site is ready for subject enrollment and all source/regulatory documents are completed. The Clinical Research Associate will also check for informed consent documents and confirms the site has Institutional Review Board approval.
The Institutional Review Board/Privacy Board is responsible for protecting the rights and welfare of human participants in accordance with federal and state regulations, as well as with institutional SOPs. The IRB reviews all human subject research under the OneMSK platform and monitors ongoing research. The IRB is comprised of two groups that meet biweekly on alternate weeks.
The Human Research Protection Program (HRPP) provides oversight to the IRB and continuing education and guidance to MSK investigators and research staff. MSK has a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) in order to certify compliance with the regulations set forth in 45 CFR 46, 21 CFR parts 50, 56, 312 and 812 and the Privacy Rule in 45 CFR parts 160 and 164.
FWA Number: FWA00004998 (expiring 5/20/2019)
IRB A Registration Number: IRB00000273 (expiring 9/28/19)
IRB B Registration Number: IRB00009377 (expiring 9/28/19)
The review process is complete once the protocol is approved by the Institutional Review Board (IRB) and is designated as open to accrual. The approval by the IRB and the ability to accrue patients may not occur simultaneously depending on the status of study requirements (e.g., budget, contract, internal study tools, etc.). PAC’s involvement will end once the protocol is open to accrual, at which point the individual study team will become the main point of contact for all protocol related activities.
In order to meet activation goals, it is requested that all final protocol related documents are available from the sponsor at the time of PAC submission (e.g., lab manuals, pharmacy manuals, etc.).
The goal is to complete the submission process through the committees in < 75 days.