Well written cover letter that details exactly what is being submitted to the IRB can greatly assist the IRB Office and help make processing the action more efficient. This is particularly true for amendments and responses to the IRB's request for modifications. A cover letter is not usually necessary for a new protocol or for a continuing review application.
Cover letters should thoroughly explain how the investigator has addressed the IRB's concerns or explain the changes in the proposed amendment. To assist investigators in their communications with the IRB, example Cover Letters and directions for formatting a cover letter are included below
Guidance for Writing a Cover Letter: Format and Content
- Address the letter to the Chair, CHOP IRB (currently, Dr. Barbara Engel);
- Ensure that the PI’s contact information (name, current email address and phone number) is on the letter.
- Ensure the IRB # and study title is the first page of the cover letter.
- Note what the action is being requested (e.g., continuing review, request for a modification, etc.)
- If the action is an amendment, provide a statement briefly summarizing the amendment.
- If the sponsor’s amendment includes a detailed list of changes, the cover letter need only have a brief summary of the major change(s).
- If a detailed list of changes has not been provided by the sponsor or study group, or if the study is investigator-initiated, a detailed list of the changes is should be included in the cover letter. The rationale for each change should also be provided so that the IRB can understand the reason(s) for each change. See the IRB’s Template Amendment Letter for the IRB’s preferred format.
- Include a list of all materials that being submitted.
- Ensure that the documents are named in a manner which will allow non-Study team people to identify the document contents. The IRB strongly recommends starting the name of protocols and consent forms with the IRB number (e.g. 12904_Protocol_tracked 6-10-10).
- Be sure that the submitted documents include their updated version number and date.
- Make sure that all specifics needs or requests are clearly articulated (e.g. just-in-time submission).
Example Cover Letters
Response to Stipulations Cover Letter: An example of a cover letter to respond to the IRB's request for modifications to a study, amendment or continuing review application.
Amendment Cover Letter: An example for a cover letter to accompany a request to amend an approved study. The letter includes an example of the IRB's preferred format for listing the detailed changes proposed in an amendment.