This plan serves as guidance in the transfer of previously approved MMC IRB clinical trials to Chesapeake
IRB. This procedure and processes have been developed to assure the continuous protection of the rights and welfare of clinical trial subjects, retain continuous IRB oversight and assure a smooth transition of IRB review and oversight with minimal disruption to research activities.
1. Ensure the Chesapeake IRB registration number has been linked to the MMC IRB FWA number prior to study transfer plan activation.
2. Share the list of studies identified (25) (currently enrolling and continue enrolling for approximately
3 months, industry sponsored studies) overseen by MMC IRB with the Chesapeake IRB so they can inform us of which studies they have previously reviewed. If previously reviewed the Chesapeake
IRB may allow an expedited or abbreviated submission process. This will be handled on a case by case basis.
3. Effective study transfer dates will be based on several factors, they include: o Study expiration date – to prevent a lapse in IRB coverage o Study status – open to enrollment/accrual o Industry sponsored drug or device studies
A roster of studies to be transferred will be retained which includes the PI name, email, coordinator name, email, MMC IRB number, study title, initial MMC IRB approval, sponsor, sponsor contact information, current expiration date, total subjects enrolled last year, total subjects enrolled all years, and current enrollment status.
4. The Chesapeake IRB will conduct an initial review of the original study recognizing that a new anniversary date for the study may be established. Once the Chesapeake IRB has approved the study transfer, MMC IRB will be notified and the transferred study will be terminated from MMC IRB oversight. MMC IRB will provide the clinical site a letter confirming the transfer and termination with MMC IRB.

5. The informed consent and assent of the transferred study will be revised to reflect the Chesapeake
IRB contact information. MMC/MMP subjects will be appropriately notified of the change in IRB oversight and provided with the new IRB’s contact information.
Study Transfer to Chesapeake IRB Checklist
Item # Task to be completed by the Research Coordinator /
Principal Investigator
Alert all members of the clinical study team that the study is in process of transfer
Register on the Chesapeake IRB web site for access to
CIRBI and the online application
Read the Chesapeake IRB Investigator Handbook for instructions on using their web site and CIRBI software.
Alert Wendy Shaw (P M Research Contracting) that this study will be moving to Chesapeake and the contract will need to be amended to include reference to Chesapeake
IRB instead of MMC IRB.
Alert the study sponsor of the transfer (may use the
Dear Sponsor letter)
Identify and upload documents to the Chesapeake IRB application:

Most current approved study Protocol

Amendments if not included in the most recent version of the Protocol/ICF

Most current approved Informed Consent


Forms/Assent forms
Investigator Brochure or Instructions for use
Patient education materials or documentation
(subject diary, scales, testing materials etc.)

Recruitment information (i.e. advertising , public information)

Other documents – list:
Provide Chesapeake (within the online application) the name and address of the sponsor contact for invoicing of
IRB fees – if applicable alert your program manager to ensure billing continuity.
Log on and keep track of when the Chesapeake IRB approval will be circulated directly to the CRC/PI and the
Local MMC IRB. Upon receipt of the completed review alert study team members of the result.
Maintain all regulatory correspondence with
Chesapeake IRB according to instructions from the study sponsor and in accordance with MMC GCP SOP’s.
Communicate directly with the Chesapeake IRB regarding all subsequent regulatory requirements (such as; submission of New Information (amendments),
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Unanticipated Events, Serious Adverse Events, Protocol deviations, violations, exceptions, and annual continuing review)
Please note that the MMC HRPP will continue to monitor the adherence to “Good Clinical Practice” in
Research at MMC/MMP and your study may be selected for review by the SEQuR program
Please be reminded that the successful transfer to Chesapeake IRB will require documentation of IRB approval from Chesapeake and documentation of completed changes to the CTA/Contract if applicable.
Date task completed
Item # Task to be completed by the Research
Compliance office of the MMC IRB
Add Chesapeake IRB to the MMC IRB FWA
Provide Chesapeake IRB with the legal language that is required in all MMC/MMP Informed
Consents
Provide Chesapeake IRB with the list of currently enrolling industry sponsored studies consider a possibility for transfer (to determine if they have reviewed these at a different site and if there is an expedited process for review)
Identify and prioritize the studies that will be transferred to Chesapeake IRB (enrolling, industry sponsored) prioritized according to the expiration date.
Alert the PI and CRC that their study will be transferred to Chesapeake IRB , provide instructions for their next steps (above)
Verify with Wendy Shaw that she has been notified of the pending transfer and will determine the impact on the CTA/Contract
Alert PI and CRC that they should notify the respective Project Manager (if applicable) to ensure billing continuity.
Upon receipt of the Chesapeake IRB review, create an action in the data base documenting the result of this review, the action may be maintained in a PENDING status until the
CTA/contract has been finalized.
Verify the status of the CTA/Contract with the PI,
CRC or Program Manager for Contracting. When the contract is complete and signed by both parties (if applicable) create an action in the database for “Study Termination” adding CHES to the IRB number and change the study status to
Central IRB.
Generate a study termination letter and provide
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this to the PI and CRC for maintain in their regulatory file.
MMC HRPP will monitor compliance to GCP SOPs directly in communication with Chesapeake IRB and has the authority to review all studies taking place at MMC/MMP at any time.
Please be reminded that the successful transfer to Chesapeake IRB will require documentation of IRB approval from Chesapeake and documentation of completed changes to the CTA/Contract if applicable.
Please note that the MMC HRPP will continue to monitor the adherence to “Good Clinical Practice” in
Research at MMC/MMP and your study may be selected for review by the SEQuR program
Pertinent Information
The following Federal wide Assurance (FWA) and IRB Information will be needed in completing sponsor specific information /forms. Chesapeake IRB will serve as the local IRB of record under the MMC federal wide assurance number
FWA: Parent Institution: Maine Medical Center
FWA#: 00003993/Expires 02/24/2017
IORG 00000154/Expires 02/24/2015
IRB 00000262 Maine Med Ctr
Chesapeake IRB Address and Phone:
Chesapeake Research Review Inc.
7063 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
Phone 410-884-2900
IORG # 00000790
The Chesapeake IRB meeting schedule and membership roster can be downloaded from the reference materials section when logged into their website CIRBI.
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