GUIDANCE FOR COMPLETION OF AN AMENDMENT FORM
Institutional Review Board
Human Subjects Research
Naval Medical Center Portsmouth, VA
Contact Clinical Investigation Department at 953-5939
This is not the form. The form is a separate document which can be located on the CID SharePoint page. Please do not return this guidance document with your form.
A request for modification of study materials must be approved by the IRB before the change may be implemented. Whether the changes are substantive enough to require review by the Full Board is initially assessed by CID, but ultimately left to the discretion of the IRB Chair or Vice Chair. You may refer to the RSPD IRB SOPs for an overview of modifications which are generally viewed as requiring Full Board review and those which may be approved under Expedited review.
To request an Amendment, an investigator should submit an Amendment form and documents with yellow highlighting to indicate revisions. Highlighted documents may include such items as protocols, consent form(s), investigator brochures, questionnaires, or advertising/recruitment materials. If a change in study personnel is requested, the Amendment (personnel) Supplemental form must be submitted, documenting the incoming research team member’s Human Use Assurance and Conflict of Interest statement. Current CV and documentation of CITI training for incoming personnel must be included. Materials required for expeditable amendments are the same as those required for Full Board amendments.
Modifications requested by Amendment must receive final approval from the Commanding Officerafter IRB approval has been obtained. This approval is documented when the minutes in which the action is reported are signed by the CO. Study changes may not be implemented until the CO-signed minutes are returned to CID. At that time, the IRB Administrator reconciles the event package and notifies the investigator that final approval has been granted and the modifications may take effect. Investigators must be mindful of this requirement for CO approval when developing a timeline for submission of their Amendment to the IRB.
AMENDMENT FORM
Study Title: Be certain that your study title matches across all documents. Please remember to include your IRB# as the beginning of your study title (NMCP.2017.0001 “TITLE”)
Principal Investigator: Enter your Rank, First and Last Name, and degree (MD, DO, PhD, etc.) in the appropriate field.
Command: Identify your Command.
Department: Identify your Department.
Phone/Pager: Identify the best phone number/ pager number to reach you.
Email Address: Identify the best email address to reach you.
Status: Indicate if the PI is Active Duty or a Civilian. Contractors cannot serve as the PI on a protocol.
PRD: Identify the month and year of your Projected Rotation Date. Enter N/A as appropriate.
CITI: Identify the date of completion of your “Investigators and Key Research Personnel-Biomedical” CITI training in month / day/ year format.
CV: Identify the date of your CV in month / day/ year format.
Research Integrity Training: Identify the date of your RIT in month / day / year format.
SUBJECT STATUS
Age of Subjects: Identify your approved age range. This information is located in your initial approval package and/or Research Plan.
Record/Specimen Collection:
If the protocol involves only the collection of data/records:
Total Records IRB Approved: Identify the total number of records approved by the IRB. This information is located in your initial approval package and/or Research Plan.
Total Records Collected: Identify the total number of records collected to date.
Record Collection Ongoing / Completed: Indicate if the protocol is currently collecting data/records or has completed collecting data/records.
Active Subject Participation:
If the protocol involves active subject participation:
Total Subjects IRB Approved: Identify the total number of subjects approved by the IRB. This information is located in your initial approval package and/or Research Plan.
Total Subjects Enrolled: Identify the total number of subjects enrolled to date.
Total Subjects Currently Active: Identify the total number of subjects who are currently active.
Enrollment Open / Enrollment Closed: Indicate if the protocol is currently open or closed to enrollment.
PROTOCOL STATUS
Identify the level of review for this protocol. This information is located in your initial approval package.
Indicate if the protocol is minimal risk or greater than minimal risk. This information is located in your initial approval package.
WHAT KIND OF AMENDMENT ARE YOU REQUESTING?
Identify what kind of Amendment is being submitted. Choose all that apply.
Be mindful that if your protocol involves collaboration covered under an agreement (CRADA, MOU etc.) the scope of your changes may require modification to the agreement as well. For guidance, please contact the Research Agreements Officer at 953-5939.
BRIEF SUMMARY OF REQUESTED MODIFICATION:
In the space provided, summarize what changes are to be made. Attach a more thorough Summary of Changes document as needed, particularly for sponsored materials and highly-detailed modifications.
For example:
- Remove CDR A from the study as the PI and add CDR B as the incoming PI;
- Move CDR X from the role of PI to AI and move CDR Y from the role of AI to PI;
- Remove CDR Z from the study as an AI;
- Request an increase in enrollment from 100 subjects to 500 subjects [include reason];
- Revision of Research Plan to add study procedure X, collection of new data ABC, and increase the number of study visits from Y to Z;
- Request the addition of data collection tool XXXX;
- Request enlarging the data window for records review. The currently approved window is
[01 Jan 15 through 31 Dec 15]. Add additional retrospective dates [01 Jan 14 through 31 Dec 14] and additional prospective dates [01 Jan 16 through 31 Dec 16].
FOR PERSONNEL ADDITIONS
Complete the table for each individual to be added. ONLY list people to be added to the project – existing investigators’ information should not be included here.
Submit the Amendment – Signature Pages for Personnel Additions form to document signature on the Human Use Assurance, Conflict of Interest Declaration, Research Monitor Statement (as needed), or Extramural Command Support of Associate Investigator Statement (as needed). Be certain to attach training and credentials (CITI, CV, and RIT) for individuals being added to the study.
Be mindful that your personnel changes may impact other approved documents, such as the Research Plan and consent form. A change in PI will always require submission of a revised Research Plan and consent form, reflecting the change in study leadership.
Please note that PI and Research Monitor changes to greater than minimal risk protocols require Full Board review
ELECTRONIC SUBMISSION CHECKLIST
Use this checklist to make certain that all necessary documents are being included in the submission package.
Guidance for Amendment Form CompletionVersion 12 September2017Page 1