Aahrpp Document # 10

AAHRPP DOCUMENT # 10

UNIVERSITY OF ALABAMA

HUMAN RESEARCH PROTECTION PROGRAM

FORM: CHECKLIST FOR POST-APPROVAL MONITORING OF EXPEDITED AND FULL BOARD PROTOCOLS (LONG FORM)

NOTE: This form is for use by investigators and Research Compliance Managers. All elements may not be applicable to all protocols. Additional questions may be added to cover unique aspects of protocols.

Responsible Investigator: ______IRB#:______

Approval Period______Monitoring Date:______

Protocol Title: ______

1. Consent Process: Comment on strengths or deficiencies below:

CONSENT PROCESS / YES /

NO

/

N/A

1. Was a waiver granted(f yes, skip this section).
2. Was a written consent form required?
3. If required, was an IRB approved / stamped consent form available, signed and dated by the subject?
4. If required, was it signed prior to entry?
5. If required, was it the correct approved / stamped version (check expiration date)
6. Was an oral consent process required (not written)?
7. If oral, was the approved script used?
8. If oral, was the subject’s consent documented?
9. Was another type of consent process required (use of translator, legally authorized representative, etc.)?
10. If other, was the process followed and documented?
11. If re-consenting or verification of ongoing consent is required, was that process followed and documented?
12. Are consent forms present for all participants—number of consents and participants are equal; participants who stopped participating or were removed from study are accounted for.
Comments:

1. Eligibility: All eligibility and ineligibility requirements as listed in the protocol should be carefully checked. Below is a general list, but others may apply and should be commented on in the “other” space. Comment on any deficiencies found.

ELIGIBILITY / YES / NO / N/A
1. Are sample criteria for age met?
2. Are sample criteria for gender met?
3. Are sample criteria for race/ethnicity met?
4. Are sample criteria for medical/psychiatric diagnosis met?
5. Are sample criteria for personal or family circumstance (parent of autistic child, caregiver to dementia patient; immigrant to US, recently bereaved, etc.) met?
6. Other (specify)
7. Other (specify)
8. Other (specify)
9. Other (specificy)
Comments:

1. Recruitment: All materials. Comment on any deficiencies found.

RECRUITMENT / YES / NO / N/A
1. Did recruitment process follow the approved protocol?
2. Did the advertisement / education materials match those approved?
Comments:

1. Intervention: Check all interventions as reported (e.g., survey, interview). Comment on any deficiencies found.

INTERVENTION / Initial / Subsequent
YES / NO / N/A / YES / NO / N/A
1. Is there a training manual, script, or other form of procedure provided?
1. Was approved protocol followed (approved instruments, tests, procedures, activities were used)?
2. Are drugs and devices being used as approved?
3. Were incentives used?
4. If so, was receipt documented?
Comments:

1. Unanticipated Events: All unanticipated events claimed, reviewed and verified. Comment on any deficiencies found.

UNANTICIPATED EVENTS / YES / NO / N/A
1. Are unanticipated events recorded in the research records?
2. . If research is sponsored, were sponsor requirements for reporting of unanticipated events followed?
3. Was the UA IRB notified of unanticipated events?
4. Is there a protocol-specific training manual or procedure available for identifying, recording, and reporting unanticipated events?
5. Has the investigator received complaints about the study?
6. Are complaints recorded in the research records?
4. Was the UA IRB notified of complaint?
5. Did the investigator respond to the complaint?
6. Was the complaint(s) satisfactorily resolved?
Comments:

1. Recordkeeping / Security:Comment on each point below.

RECORDKEEPING / SECURITY /

YES

/ NO / N/A
1. Were the records legible and organized?
2. Did electronic data match the paper records?
3. Was all required and necessary information provided?
4. Were security measures in place to protect privacy and confidentiality (e.g., locked, coded)?
5. Did security measures follow the approved protocol?
Comments:

G. Investigator and Key Personnel Training. Ask PI to identify co-investigators and key personnel. List below.

INVESTIGATOR & KEY PERSONNEL TRAINING / CURRENT-YES / CURRENT-NO / N/A
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11. Are manual/plans for staff training being followed?
12. Are manual/plans for staff supervision being followed?
Comments:

H. EVALUATION OF DEVIATIONS FROM PROTOCOL BY CATEGORY

Circle the Rating for Each Category of Deviation

Minor: Deviations that do not affect the outcome or interpretation of the study, or the risks to the subject.

Major: Deviations from protocol-specific procedures that makes the resulting data questionable or increases the risk to the subject.

1. CONSENT:

Rating:OKMinor Major

Comments:

______

2. ELIGIBILITY:

Rating:OKMinor Major

Comments:

______

3. RECRUITMENT / EDUCATION:

Rating:OKMinor Major

Comments:

______

4. INTERVENTION (And/Or Instruments):

Rating:OKMinor Major

Comments:

______

5. UNANTICIPATED EVENTS:

Rating:OKMinor Major

Comments:

______

6. RECORD-KEEPING / SECURITY:

Rating:OKMajor Major

Comments:

______

Summary and Comments:

Monitor Signature/Date______

Monitor Signature/Date______

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