Amendmentsubmission Checklist

Amendmentsubmission Checklist

AmendmentSubmission Checklist

The checklist below describes the required information/items for IRB submissions. The research team is encouraged to use this checklist to avoid delays with processing and IRB review. Please note: the IRB Office staff utilize this checklist as a part of the pre-review process. However, an individual submission may be returned due to other issues, on a case-by-case basis.

  1. Have all revisions been summarized in the Amendment Information section (If a section has a check mark, please confirm that the amendment information section includes these changes. If the section is not mentioned, return the submission and ask them to outline the changes in that section)?

[ ] YES [ ] NO [ ] NA

  1. Has a rationale/justification for all revisions in the Amendment Information section been provided? This is needed for any changes, including updates to research personnel, changes to recruitment, changes to study design, etc.

[ ] YES [ ] NO [ ] NA

  1. If the amendment involves a change to the eIRB application, have the changes been made to the appropriate sections of the eIRB protocol?

[ ] YES [ ] NO [ ] NA

  1. If the amendment involves a change to a study document (e.g. consent, HIPAA, advertisements, subject diaries, subject information forms, etc.), have tracked and clean PDF versions of the revised documents been attached? Please note that any change to the above referenced documents (even minor changes such as updated footers) requires both tracked and clean PDF versions.

[ ] YES [ ] NO [ ] NA

  1. If the study is ‘Open’ or “Open, closed to subjects accrual’ does the Amendment Information section include a statement about the number of active subjects still receiving study intervention or those that are in long term follow-up.

[ ] YES [ ] NO [ ] NA

  1. If the amendment is a sponsor-initiated amendment, have all relevant sponsor documents been uploaded into the Attachments section, including, but not limited to the sponsor amendment, the summary of changes, etc.?

[ ] YES [ ] NO [ ] NA

Tips for Common Amendment Submissions:

  1. Addition of a co-investigator:
  2. If the co-investigator is a WCM/NYP employee that is not showing up in the drop-down menu, please send an email to and request the IRB staff to “map” the investigator. Please include the investigator’s name, full email address and department affiliation.
  1. Has the added co-investigator completed the appropriate CITI training? If not, approval documents will not be released until this training requirement is completed.

[ ] YES [ ] NO [ ] NA

  1. If the co-investigator is an external personnel (i.e. not WCM/NYP), please upload a PDF document entitled, “List of External Co-Investigators” which includes the external investigator’s name, institutional affiliation, contact information and role on the study (e.g. data analysis, subject recruitment, etc.). Please note that the external investigator will also need to submit an External Study Specific Report (SSR) and submit proof of human subject research training as required by their home institution.

[ ] YES [ ] NO [ ] NA

  1. If adding/removing a student investigator, has both the Non-Technical Research Plan (NTRP) and the PI/Co-Investigator list been updated to reflect this change?

[ ] YES [ ] NO [ ] NA

  1. Increase/decrease in enrollment/accrual numbers:
  2. If increasing/decreasing the number of expected subjects to be enrolled (or for chart studies, the expected number of charts to be reviewed), has both the Subject Population section and the consent form (if applicable) been updated?

[ ] YES [ ] NO [ ] NA

  1. If this is a tissue procurement study and the tissue to be collected has changed, has an updated Pathology approval been obtained?

[ ] YES [ ] NO [ ] NA

  1. Does the amendment now indicate that the protocol will now be using the WCMC-DSMB? If yes, do not issue the approval until the PI provides the DSMB approval letter to the IRB.

[ ] YES [ ] NO [ ] NA

  1. Is the protocol a gene transfer study or involve the use of a non-FDA approved Biological agent (the answer to one of the questions in the Institutional Biosafety section is yes). Please check with the IBC administrator to determine if IBC review of the amendment is required.

[ ] YES [ ] NO [ ] NA

  1. Addition of a grant/request for 310 form:
  2. Has the Funding Source and Additional Information sections been updated?

[ ] YES [ ] NO [ ] NA

  1. Has all necessary grant-related documents and information (e.g.grant and the human subjects research section, grant-giving organization name, PI of the grant, etc.) been attached in order to generate the 310 form?

[ ] YES [ ] NO [ ] NA

Tips for Research Teams:

In the Amendment Summary, please provide the language you wish to see referenced in approval documentation. Alternatively, please attach a memo, which includes this language along with any documents that should be referenced in an approval letter. In the Amendment Information questionnaire, please provide a more detailed description of all changes and the rationale for them.

Please note that symbols representing “greater than or equal to” ( ), “less than or equal to” (), “alpha” or “beta” often translate into nonsensical symbols in eIRB. In these cases, please spell out the words or phrases instead of using the symbols.

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