SUBMISSION/REQUEST FOR AMENDMENT TO PREVIOUSLY APPROVED RESEARCH
Tufts Health Sciences Institutional Review Board (IRB)
800 Washington Street, Box 817
Boston, MA 02111
Principal Investigator: [Insert PI name]
IRB #: [Insert IRB number]
Study Title:[Insert study title]
Amendment #:[Insert identifier for the amendment, such as Amendment # 2, or Protocol version 3]
[Include the following points, deleting those that are not applicable in colored font]
I, the Principal Investigator, have reviewed this amendment and have made the following assessments:
1)Provide a description of the amendment:
2)Provide the rationale for the amendment:
3)State where this amendment originated (Sponsor or PI). If the amendment did not originate from the Sponsor, provide documentation that the Sponsor is aware of this amendment:
- The Sponsor noted [describe the Sponsor’s assessment about ICF revisions, expectations for re-consent, etc. and include documentation of this, as applicable]
- Provide any relevant documentation from the Sponsor about this amendment (letter, memo, or e-mail from Sponsor).
4)Provide an assessment of how the amendment alters, or does not alter, the risks and benefits of the study. Explain whether the proposed amendment increases or decreases the level of risk to participants (thereby changing the risk/benefit ratio) and, if so, describe. If the level of risk remains the same, please state that:
5)Clearly identify all proposed changes in this letter, or refer to a specific document that contains a detailed list of changes (for example, a sponsor document detailing all changes). Make sure you don’t accidentally put things into a consent form or protocol document if they are not listed/discussed as proposed changes in this letter or an attached detailed amendment summary. The IRB needs to be sure all components of an amendment are considered and approved. Please also submit tracked and clean copies of all revised documents.
6)Ifthe study is receiving federal funding, confirm that revisions to the protocol do not require revisions to the grant and that the protocol is still within the scope of the grant:
7)If the study title is being revised, please provide the new title:
8)[Re-consent: If the ICF is being revised, state whether or not you plan to re-consent previously enrolled subjects withthe new information. (Consider whether the new information might affect a subject’s willingness to continue to participate in the research study.) If subjects will be re-consented, provide a plan describing how and when re-consent will occur.]
9)[Increase in # of subjects:If you are proposing an increase in the number of subjects to be enrolled, please state this andprovide the rationale.]
10)[Reportable New Information:Include a statement if this amendment is theresult of a serious adverse event (SAE), unanticipated problem (UP), non-compliance, protocol deviation, or other reportable new information. SubmittheReportable New Information Form along with the amendment, or specify the date it was submitted/will be submitted to the IRB.]
11)[Investigator’s Brochure (IB): Addressthe following points for updated/revised IBs, deleting those that are not applicable:
a)Refer to IB revisions summarized on pages [## - ##].Include a summary of the changes and/ora tracked copy of the updated IB.
b)State whether the IB revisions contain information that should be included in the ICF [i.e., information that might affect a subject’s willingness to continue to participate in the research study] or revised Protocol [i.e., change in risks, changes in experience with the drug].
c)Confirm you have responded to points # 4, 8, and 13of this cover letter – or note if not applicable]
12)[Revised Documents:Consider whether the Protocol, Site-Specific Appendix, and/orICF(s) need to be revised to reflect the proposed changes.]
13)[Pharmacy: If the study has a pharmacy component, contactthe Investigational Drug Service (IDS) (617-636-3202) and include a statement such as “We have contacted the investigational drug service (IDS) to ensure the most recent Protocol, Site-Specific Appendix, and Investigator’s Brochure are on file with the pharmacy.”]
14)[Radiation: If the study involves research radiation, consider whether Form 4 needs to be updated. If so, please submit a revised Form 4, signed by the Radiation Safety Officer.]
15)[Specimen Banking: If the study involves specimen banking, consider whether the Form 6 needs to be updated. If so, please submit a revised and signed Form 6.]
16)[Translations: If translated documents are being submitted, please refer to the Tufts Health Sciences IRB Investigator Manual for document translation policy and submit theCertification of Translation/Back Translation Formand English back translations.]
17)[Change in Research Team:
- Change in PI:If this is a change in PI, submit the new PI’s COI form (regardless of responses on the COI form), and have both the former and new PI sign this letter. Revise and submit any study documents that will be altered to reflect the change in research team, for example: Protocol, ICF, recruitment materials, etc.
- Confirm the funding agency/sponsor has been informed of and accepts this change:
- Adding Research Team Member(s): To add research team member(s),complete the table below:
Addition of Research Team Member(s)
List newResearchTeam Member(s)
This includes those responsible for the design, conduct, or reporting of the research, such as the PI & Co-Is, research nurses and coordinators, project managers, etc. / Individual’s Role
For example: PI, Co-I,Research Coordinator.
Do not list any research team member as a “Co-PI;” only one person may be listed as PI for a study. / In a Training PositionFor example resident, fellow, student, etc. / Institutional Affiliation
For example Tufts MC, TUSM, HNRCA, etc. / Current CITI
Certification:
Indicate the expiration
date of each individual’s CITI certification. / Current GCP
Training1:
Indicate the expirationdate of each individual’s GCP Training
Check N/A if this does not apply to this study: N/A / Conflict of Interest (COI) FormCompleted:
If any “Yes” responses are indicated, submit the form to the IRB.
If there are only “No” responses indicated, retain in your study files only.
NOTE: IRB COI review is always required for change in PI.
1 GCP training is required for NIH funded clinical trials (NIH funded studies that meet the NIH definition of clinical trial).
As of 01 January 2018, GCP training will be required for allclinical trials, regardless of funding source.
- Removing Research Team Member(s):To remove research team member(s), list their names]
18)[Funding source: If you are informing the IRB of a new funding source or a change in funding source, describe these changes and include a copy of the grant, as applicable.]
The current enrollment status of the study is [there has been no enrollment to date / enrolling subjects / closed to enrollment].
The total number of subjects enrolled to date is [insert # of subjects enrolled].
The total number of subjects being followed is [insert # of subjects being followed].
Enclosed documents - All changes to documents (ICF, protocol, advertisements, etc.) must be specifically listed/ discussed as a proposed change in addition to being tracked within the document in order to adequately inform the IRB of the changes. The IRB needs to be aware of all components of an amendment:
Previously approved documents that are being revised:
- Protocol tracked version [Version Date: ]
- Protocol updated version [Version Date: ]
- Informed Consent Form tracked version [ Version Date: ]
- Informed Consent Form updated version [ Version Date: ]
- Site-Specific Appendix tracked version [ Version Date: ]
- Site-Specific Appendix updated version [ Version Date: ]
Documents that are being newly submitted:
- Study Flyer [Version Date: ]
- Study Questionnaire [Version Date: ]
- Telephone Script [Version Date: ]
Please contact me at [telephone / e-mail] or the study coordinator, [name, telephone / e-mail] if you have any questions.
Sincerely,
Principal Investigator’s original ink signature
Name of Principal Investigator