PRINCIPAL INVESTIGATOR’S COMPLIANCE ASSESSMENT
An annual clinical research Compliance Assessment is required to be completed for all greater than minimal risk active studies being conducted under the University of Pennsylvania’s Human Research Protection Program.”
The Compliance Assessment for the prior year’s activity should be completed within 90 days of the IRB approval expiration date. All the documentation regarding the compliance assessment should be filed by you or your clinical research support staff in the Monitoring section of the Regulatory Binder to demonstrate your ongoing assessment of the research conduct. As the PI you will be prompted to complete a Compliance Assessment affirmation statement confirming that you have completed the assessment at the time of the CR submission to the IRB. Please do not upload the Compliance Assessment into HS-ERA.
Instructions for Completing the Compliance Assessment:
· Answer applicable questions for the study.
· Document any finding and comment on any question for which the answer requires clarification.
· If comments for a specific question require more space, provide abbreviated comments in the appropriate column, and enter the complete information on section “8.- Comments / Others” at the end of the report, indicating the section it is referring to.
· If the study has been audited/monitored during the 90 days prior to IRB approval expiration date, some of the questions might be answered by referring to the information provided by the audit/monitoring report.
The OCR and /or the IRB can be reached for support related to any aspect of the assessment:
· OCR contact information: or call215.746.8334
· IRB contact information: or call 215.573.2540
1 as defined by the IRB at time of last review
2 active means subjects enrolled with ongoing study related procedures
Protocol #: / Principal Investigator’s Name:Person performing the Compliance Assessment:
Name:
Role: / Date of Compliance Assessment:
Date of last Clinicaltrials.gov update:
1. Facilities, Equipment and Staff / Yes No N/A
/ Comments
a. Are the facilities and equipment adequate to conduct the study?
i. Is there enough space for keeping the files, study medication and materials, obtaining consent, and interacting with the study subjects?
ii. Is the space appropriate for those activities? i.e. Private space for consenting, secure space for study documentation, investigational product and materials
iii. Do you have all the materials required to properly and safely conduct the study?
b. Is there current documentation of PI delegation of research responsibilities i.e., Delegation of Authority log (DoA log)?
i. Have the new study personnel been added to the DoA log?
c. Are all study staff only performing tasks for which they are qualified and trained?
i. Ensure CVs, Licenses, CITI training, CRC certification, and documentation of financial disclosure for the applicable personnel are on file
ii. The following tasks may only be performed by an appropriate licensed medical professional who is also the
PI or sub-investigator:
· Eligibility criteria sign off
· Review of test result (labs, EKG, etc.)
· Investigational product prescription
· Physical exam
· Adverse event assessment
d. Is protocol training of all personnel properly documented?
i. Ensure documentation of who provided and received the training, when the training happened, and the subject matter of the training
ii. Ensure there is documentation of training for the new study personnel as per their responsibilities
iii. Ensure re-training documentation of the necessary staff for all major protocol amendments
2. Informed Consent and HIPAA Authorization: / Yes No N/A
/ Comments
a. Is there documentation that all subjects have provided informed consent and HIPAA Authorization prior to start of study procedures?
i. Ensure appropriate version, with the IRB stamp was used
ii. Ensure all consents are complete and the signature and dates of both parties match
iii. Ensure re-consents and consent addenda were obtained if required
3. Study Enrollment / Conduct / Yes No N/A
/ Comments
a. Is there source documentation (EPIC, paper records, etc) to verify inclusion/exclusion criteria?
b. Are all subjects eligible for this study?
i. If no, confirm that the deviation has been reported to the IRB and/or sponsor per reporting requirements
c. Has eligibility been reviewed and documented appropriately by the PI or appropriate designee?
d. Are all study procedures being performed per protocol, and within the allotted window?
ii. If a procedure or visit was missed, completed out of the allotted window, or not completed, was the reason properly documented?
iii. If no, confirm that the deviation has been reported to the IRB and/or sponsor per reporting requirements
e. Are CRFs consistent with source document?
iv. ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialed by the appropriate study personnel
4. Regulatory Binder / Yes No N/A
/ Comments
a. Are all safety reports and any other safety-related study information (i.e. new package insert, label, IB, etc.) filed and submitted to the IRB per IRB policy?
b. Is documentation of correspondence with the IRB, Sponsor, other reviewing entities (i.e. CAMRIS, CTRC, etc.), IDS, or others current and on file?
c. Are all approved versions of the following study documents on file as applicable?
· Protocol and amendments
· Protocol Signature Page / Investigator’s agreement / FDA 1572 (as applicable)
· HIPAA / ICF and amendments
· Study approvals (IRB & reviewing entities i.e. CAMRIS, CTRC, etc.)
· CRF clean copy and completion guidelines
· Lab manual, IP administration manual, etc.
d. Study Tracking Logs
· Screening/Enrollment Log
· Adverse Event log
· Monitor visit log / monitoring visit reports / correspondence (this compliance assessment review should be entered in the log)
5. Investigational Product (IP)
If no IP skip to section 6 / Yes No N/A
/ Comments
a. Is there documentation that the IP has been accounted for according to the following criteria: receipt, dispensation, return, and destruction (include date, amount and batch# for each of these criteria)?
i. Follow link for an IP accountability log example
b. Are all IP supplies stored in a separate secured location?
c. Is the IP being stored per protocol (i.e. room temperature/refrigerator/freezer)
i. Ensure that the calibration of storage equipment and temperature logs are maintained
d. Is there enough IP on hand to sustain study procedures?
i. Check the expiration date to ensure adequate supply
e. Are certificate of analyses for all IP batches on file?
i. This is a document that details the identity, purity, and strength of the investigational product. It does not need to be filed if the IP is purchased from a commercial distributor and is used as is (package is not opened before dispensation to subject)
f. If this is a device study, has the device been maintained/calibrated as require per protocol and manufacturer?
6. Laboratory / Biological Samples
If no lab/biological samples skip to section 7 / Yes No N/A
/ Comments
a. Are normal ranges and laboratory certification (CLIA/CAP) current and on file.
b. Are there enough lab supplies (i.e. lab tubes) on hand to sustain study procedures?
i. Check the expiration date to ensure adequate supply
c. Is specimen log current and on file?
d. Are the samples being stored per protocol (i.e. use of refrigerator/freezer)
ii. Ensure that the calibration of storage equipment and temperature logs are maintained
e. Is there a receipt for each corresponding shipment on file?
7. Safety review / Yes No N/A
/ Comments
a. Has every adverse event been assessed and has this assessment been properly documented?
i. The assessment of the adverse events must be performed by a licensed medical professional who is also the PI or a sub-investigator listed on the delegation of authority log
b. Have all unexpected problems and adverse events been properly followed-up by PI or qualified sub-investigator?
c. Have all adverse events been reported to the sponsor as per protocol in a timely manner?
8. Comments / Other
Name of Person performing Signature: Date:
the compliance assessment:
Name of Principal Investigator: Signature: Date:
PI Compliance Assessment - Version 2.0 (03-Dec-2015) Page 1 of 6