HRPP / Continuing Review Checklist / CHK-2m
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Protocol reviewed: / Review completed by:
Protocol #:
PD: / Associate name:
Panel #:
Meeting Date: / Review Type: Regular
Expedited: 8a 8b 8c 9
Expedited:1 – 7
N/A / Yes / No / Check Admin Notes and incorporate into your review as necessary.
Mark all Admin Notes DONE, when applicable.
MPP or Training Grant? No – skip this section
Check Funding
Yes - “(MPP)” or “(Training Grant)” grant is attached to Section 16
Yes - Substudy list is attached
Yes - All personnel have completed CITI
Yes - Conflict of Interest (Individual)? If so notify manager
No changes (e.g., personnel, new grant, etc.) – else, note opposite: Click or tap here to enter text.
Done! Do NOT complete the questions below. They do not apply to MPP/Training Grants.
Number enrolled appropriate? If no: Click or tap here to enter text.
Not when compared to last CR
Not when compared to target number, 8a
Type of participant enrolled is not consistent w/ expected participant population
All Continuing Review questions answered completely? If no, SEND COMMENT
Click or tap here to enter text.
Open to Enrollment?
CTA with RRI. If no interventions described, SEND COMMENT
CTA with no RRI. If not permanently CTA, Regular must be Presented.
Are there modifications to the protocol? Click or tap here to enter text.
Minor changes
Substantive changes
Manufacturer added? If yes, NOTIFY MANAGER
Personnel changes? Describe: Click or tap here to enter text.
CITI completed for all personnel? Click or tap here to enter text.If Stanford is lead site or issuing sub-awards (CHECK ADMIN NOTES) – ask for IRB approval from sites at every renewal if current approval not already attached.
FUNDING:
SPO# in eP? If no, obtain through SERA or request via Comment
VA funding
If funding is no longer active, SEND COMMENT to remove inactive funding.
Federal Funding:
Federally funded chart reviews & nonmedical protocols: study is ineligible for extended continuing review period. ADD ADMIN NOTE
FUNDING CHANGES:
If adding funding,is funding appropriate to the study (funding matches protocol)? If no, notify Manager
If removing/adding funding, confirm General Checklist #11, Funding section, consent form(s) and HIPAA Authorization language are correct and consistent w/ one another.
Note: if study is in data analysis or LTFU, revising consent is not necessary.
New Federal Funding:
If adding, and Stanford is Prime awardee, is complete grant attached? If no, obtain or SEND COMMENT.
SPONSOR INVESTIGATOR – Annual Report to FDA is attached? If no, SEND COMMENT
Sponsor-Investigator – Researcher must FAX copies of 3 ICFs to 650-723-8815
Note: These executed ICFs are NOT TO BE ATTACHED in eProtocol.
HIGH RISK STUDIES (only): if 9a = high risk, and short form process is in section 13:
SEND CR – HIGH RISK COMMENT. Notify Manager.
DSMB report(s) required by monitoring plan attached? (check eP Admin Notes)
CHILDREN INCLUDED?
Parental consent box on ICF or separate parental permission
404/405 (50.51/50.52) – two signature lines
406/407 (50.53/54) – two signature lines and checkboxes
INDIVIDUAL COI
Existing Individual COI?
New Individual COI? If yes, notify Manager & ensure consent is updated.
CONSENT/ASSENT/HIPAA
Consent Forms attached in eP (including translated consents)?
If yes, indicate how many are attached: Click or tap here to enter text.
Consent additions or removals: any new consents added or removed? If yes, notify Manager
Consent versions: when revised, does each attached version match latest approved version?
If no, SEND COMMENT
Are protocol changes (e.g. funding, procedures, target enrollment) reflected on EVERY consent version?
If no, SEND COMMENT
Assent: ensure assent includes an approval date.
HIPAA (if separate)
Dates changed? Text changed?
Obligations: is there language for approval letter?
Delete items not reviewed with this event
Have all applicable Administrative Notes been addressed?
NOTES:
Click or tap here to enter text.
CHK03016 rev1411/22/2017Research Compliance Office