Northwell Health - Human Research Protection Program

Northwell Health - Human Research Protection Program

Research Compliance GCP QA Checklist

The Human Research Protection Program at Northwell Health conducts routine and for-cause reviews of research studies to ensure adherence to federal and state regulations (e.g. FDA, OHRP, HIPAA, NYS, etc.), institutional policies (e.g. Northwell Health, HRPP), and best practices such as current Good Clinical Practice (GCP) E6. GCPs are applicable to clinical trials to ensure they are conducted in accordance with ethical principles that have originated from the Declaration of Helsinki and scientific quality standards for the design, conduct, recording and reporting of research.

This checklist is used for studies that may involve investigational drugs or biologics. For device trials please use the other available Device/ISO checklist.

GENERAL INFORMATION

Name of person completing checklist: / Date:
Study Title
IRB Protocol Number
Principal Investigator
PI contact info./E-mail Address
Study Coordinator(s)
Coord. contact info./E-mail Address
Study Personnel / Reference: GCP 2.8; 4.1.1; HRPP Policy 5.1: Criteria for Approval of Research
Northwell Health Research Policy GR085: Training in the Conduct of Human Subject Research
Northwell Health Research Policy GR065: Conflicts of Interest in Research
NIH Policy NOT-OD-16-148: Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
# / Name / Role / Can obtain consent?1 / Completed HRPP Education & Registration Requirements? / Date IRB approved / Date IRB removed / Annual COI Disclosure Certified?2 / On File?
CITI(HST GCP (3yrs)),
COI (4yrs), etc.) / CV: Signed & dated w/in 2 Yrs / License
(If app)
1
2
3
4
1)Confirm training and the qualifications of each investigator who is authorized to obtain consent from subjects.
2)For any investigators with positive COI disclosures requiring a management plan, specify any restrictions noted and review for compliance with the plan (Check COISmart).
Study Staff changes since last continuing review?
If yes, was an amendment submitted to the IRB? / YES NO
YES NO N/A
Department/ Service Line
Institution(specify exact location)
Sponsor Investigator Study?
If yes, does the investigator held IND? / YES NO
YES NO N/A
Sponsor(s)
Funding
(check all that apply) / Industry Government Internal/Department
Foundation Other: ______
Other regulatory requirements that apply / FDA DOD GCP
NIH Other: ______
IRB Review / Northwell Health IRB Central IRB
BRANY Relying on other IRB (specify):______
Review type: Expedited Full Board
IRB Initial Approval Date: ______
Current IRB Expiration Date: ______
Pediatric Risk Category / Not Applicable
(1) Research not involving greater than minimal risk (§45CFR46.404, §21CFR50.51).
(2) Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual subjects (§45CFR46.405, §21CFR50.52).
(3) Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition (§45CFR46.406, §21CFR50.53).
(4) 46.407 Research not otherwise approvable which present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (§45CFR46.407, §21CFR50.54).
Enrollment #

(Enrolled is anyone who signed a consent form)

/ # IRB Approved: ______# Enrolled to date: ______
Comments:

1.REGULATORY DOCUMENTATION & RECORD KEEPING

Reference: Northwell Health Research Policy GR042: Research Regulatory Binder; ICH GCP 4.9.4, 5.5.6, 5.5.7, & 8.1-8.4; FDA 21CFR312.57 & 21CFR312.64

Depending on the type of study and sponsor, some studies require different regulatory documents. Review your regulatory documents and complete this section according to the requirements that apply to your study.

YES / NO / N/A / Reference:
1.1 / Do you maintain regulatory documents? / ICH GCP 2.10, 4.9.4, 5.5.6, & 5.5.7
1.2 / If so, what type of regulatory binder is used?
Northwell Health provided version
Northwell Health Adapted version
Sponsor provided version
Electronic version
Other: ______
1.3 / (If applicable)
Havethe study team ensured all electronically filed documents are available and easily retrievable?
1.4 / Are all approved protocols on file?
(original and all revisions) / ICH GCP 8.2.2
1.5 / Are all approved consent forms on file? (all revisions) / ICH GCP 8.2.3
1.6 / All CVs & licenses (if applicable) of key personnel on file?
Are CVs signed and dated (w/in the past 2 yrs)?
All licenses up-to-date? / ICH GCP 4.1.1, 8.2.10 & 8.3.5
1.7 / Is there a subject screening/enrollment log?
Is the subject screening/enrollment log complete?
# of subjects included? ______
# of subjects excluded? ______
Is there a subject identification code list? / ICH GCP 8.3.20, 8.3.21,
8.3.22 & 8.4.3
1.8 / Is there an auditing/monitoring log?
(Auditors please sign in on the log)
Is the log complete?
If the study requires monitoring, how frequently do reviews occur?______/ ICH GCP 8.3.10
1.9 / Is there a staff signature log?
Is staff signature log complete?
Is there a staff delegation of responsibility log (can be combined with staff signature log)?
Is the staff delegation log complete? / ICH GCP 4.1.5 & 8.3.24
1.10 / (If applicable)
Are all versions of the Investigator’s Brochure or equivalent information on file?
Product information sheet on file? / ICH GCP 7.1, 8.2.1 & 8.3.1
1.11 / Are lab tests required?
1.12 / If eligibility or treatment decisions are based on test results or when study results are shared with subjects or their treatment providers to alter care, are they done in a CLIA approved or NYS Dept. of Health certified lab? / CLIA Public Law 100-578
New York State Public Health Law Article 5, Title V
1.13 / Is a copy of normal lab values on file or the values are documented along with the test results? / ICH GCP 8.2.11 & 8.3.6
1.14 / Is a copy of the lab certification on file or readily accessible?
(For research labs where applicable) Is a copy of the Lab Director’s CV on file? / ICH GCP 8.2.12 & 8.3.7
CLIA – CMS
1.15 / Is a COI certification completed and up to date for each investigator? / 21 CFR 54; Northwell Health Research Policy GR065: Conflicts of Interest in Research
1.16 / For sponsor/investigator study,
Are there 1572 Financial Disclosures completed and up to date for key study personnel? / Northwell Health Research Policy GR097: IND-IDE Sponsor-Investigator Responsibilities
1.17 / All relevant correspondence to and from sponsor and/or FDA on file (if app)? / FDA 21CFR312; ICH GCP 4.9.4
1.18 / Is this an applicable clinical trial or NIH funded clinical trial?,
Is the study registered on clinicaltrials.gov?
# NCT______
Is the information up to date? / US Public Law 110-85 (FDA Amendments Act of 2007), Title VIII, Sec.801
ICMJE requirement
Northwell Health Research Policy GR020: Requirements for Registration of Clinical Research at
1.19 / Is there a Data Safety Monitoring Board/ Committee/Plan for this study?
If yes, did they adhere to the plan?
Are all DSMB/C reports and recommendations on file?
Have all DSMB/C reports been submitted to the IRB? / ICH GCP 6.8 & 8.3.18
HRPP Policy: Data and Safety Monitoring
Please use this section to explain any issues with Regulatory Documentation & Record Keeping:

2.Institutional AND IRB DOCUMENTATION

Reference: FDA 21CFR312; ICH GCP 4.4.1 & 4.5.1

YES / NO / N/A / Reference:
2.1 / All relevant correspondence (e.g. submissions, responses, approvals) to and from the HRPP, IRB, and IBC on file? / FDA 21CFR312.66
ICH GCP 4.4.3, 4.9.4,
8.3.3 & 8.3.19
2.2 / IRB/Institutional HRPP Initial Approval
Initial application and correspondence on file?
List items: / Northwell Health Research Policy GR056: Research with Human Subjects (IRB Approval)
HRPP Policy: Criteria for IRB Approval of Research
ICH GCP 4.4.1 & 8.2.7
FDA 21CFR312.66
IRB Response on file?
List items:
PI Response on file?
List items:
Final IRB approval & documents approved on file?
List items:
InstitutionalHRPP approval & documents approved on file?
List items:
2.3 / Continuing Review
Details / Date Rec’d by IRB / Date approved / IRB approval letter on file?
YES / NO
Continuing Review # 1
Continuing Review # 2
Continuing Review # 3
YES / NO / HRPP Policy: Continuing Review
FDA 21CFR312.66
ICH GCP 4.10.1& 8.3.3
2.4 / Was each PR submitted on time?
 If NO:
a)Was there any lapsed period(s) between approval date and expiration date?
b)Was any subject enrolled during this lapsed period?
c)If YES, was a protocol deviation submitted to the IRB? (Please explain in the comments if the deviation was not submitted)
d)Were study activities conducted during this lapsed period?
e)If yes, is there documentation of IRB approval on file?

2.5

/ Modifications (Amendments) & Other IRB Notifications / FDA 21CFR312.66; GCP 4.5;
HRPP Policy: Protocol Deviations
Change Requested / Date Rec’d by IRB / Date acknowledged/ approved / IRB acknowledgement/ approval letter on file?
YES / NO

1)

List items:

2)

List items:

3)

List items:

4)

List items:

2.6

/ Reportable Events & Protocol Exceptions / FDA 21CFR312.66; GCP 4.5; GCP 4.11;
HRPP Policy: Protocol Exceptions & Unanticipated Problems Involving Risk to Subjects and Others
Event Type (e.g.: Protocol Deviation, Unanticipated Problem, SAE, Protocol Exception) / Date of Event / Date Rec’d by IRB / Date acknowledged/ approved / IRB acknowledgement/ approval letter on file?
YES / NO
1)
List details:
2)
List details:
3)
List details:
4)
List details:
5)
List details:
6)
List details:
2.7 / Any reportable events not reported to the IRB (or HRPP for external IRBs)?
Have any of the following issues been reported by PI:

New information that might adversely affect the safety of the subjects or the conduct of the clinical trial
Any changes significantly affecting the conduct of the clinical trial or increasing risk to subjects

If Yes, provide details and recommendation:
2.8 / Any sponsor-approved protocol exceptions? YES NO N/A
 If YES, have they been approved by the IRB prior to implementation? YES NO
2.9 / IRB Approved Protocol and Consent Versions / FDA 21CFR312.66; GCP 4.4, 4.8, 4.9, 8.2.2, 8.2.7
Approved protocol version date / On file? / Approved consent version date/with IRB stamp date / On file? / Approved ASSENT version date if applicable/with IRB stamp date / On file? / Comments (please describe the differences from the previous version)
2.10 / Who prepares: (Check all that apply) / PI / Co-I / Coordinator / Other ______
Progress report to the IRB?
AE and SAE Reports/ Reportable Events?
Modifications?
Any quality recommendations for the protocol /consent documents?
Please use this section to explain any issues with IRB Documentation:

3.SUBJECT RECRUITMENT PROCEDURES

Reference:
3.1 / Are recruitment methods stated in the protocol? / YES NO / HRPP Policy:
Recruitment of Subjects
ICH GCP 8.2.3, 8.3.2 & 8.3.3
3.2 / How are potential subjects identified?
(check all that apply) / Medical Record Review
Inpatient
Outpatient/MD Office/Clinic
Database
Contact from Recruitment
materials
Other: ______
YES / NO / N/A
3.3 / Approved recruitment materials
(original and all revisions) on file?
3.4 /

Are there any changes to recruitment materials since last continuing review?

3.5 /

If yes, was amendment submitted to IRB?

3.6 /

Who is responsible for subject recruitment?

/ PI; Coordinator; Co-I; Other______
Reminder: Subjects should be given a copy of the hospital’s HIPAA notice of privacy practices if not received at delivery of first service within the organization. / Northwell Health Research Policy 800.45: Notice of Privacy Practices
Please use this section to explain any issues with Subject Recruitment Procedures:

4.INFORMED CONSENT PROCESS

Reference: FDA 21CFR312.60; ICH GCP 4.8, 4.9; GR010 Northwell Health Research Policy: Informed Consent; Northwell Health Policy 100.23 Informed Consent and LEP

4.1 / List the types of consent forms used (e.g. healthy volunteers, affected, minor or adult subjects, etc.)
4.2 / Where are the original signed consent forms kept? /

Reference:

ICH GCP 8.2.7, 8.3.3 & 8.3.12
HRPP Policy: Documentation of Informed Consent
4.3 / Where are copies of the signed consent forms kept (e.g. MR, subject file, etc.)?
YES / NO / Reference:
4.4 / Were any invalid consent forms used?
(Includes use of a consent without an IRB approval stamp, expired or incorrect consent)
If yes, was a protocol violation submitted to IRB? / HRPP Policy: Informed Consent and LEP
FDA 21CFR312.60
ICH GCP 4.8.8 & 8.3.12
4.5 / For LEP,
If applicable, were translated short forms used?
If Yes, were translated HIPAA forms used?
If No, was a protocol violation submitted to the IRB?
4.6 / Did each subject/LAR sign his/her own consent form?
Did each subject/LAR date his/her own consent form?
List the subject files chosen for subject case reviews.
Add additional space as necessary to accommodate the number of chosen subject files.
4.7 / Subject study ID# on file / Comments
Subject #1:
Subject #2:
Subject #3:
YES / NO / Reference:
4.8 / Are there enrollment notes written for each subject that were signed and dated by individual who wrote the note?
If so, is a copy of the enrollment note and consent form placed in the subject’s inpatient or outpatient chart (as appropriate)? / HRPP Policy: Informed Consent
4.9 / Did each subject receive a copy of the signed consent form?
Is subject’s receipt of a copy of the signed consent form documented? / HRPP Policy: Informed Consent
ICH GCP 4.8.11
5.0 / For studies with multiple visits (if app):
As informed consent is an ongoing process, is there documentation (e.g. notes or re-consent when necessary) of the subject’s willingness to continue, when new information becomes available and may affect their willingness to continue OR when their status has changed?
(It is also recommended that the following assessments are documented:

How the subject is doing on study
Clinician’s recommendation for continuation or discontinuation of participation)

/ HRPP Policy: Informed Consent
Quality Improvement Recommendation
Roles & Responsibilities / PI / Co-I / Coordinator / Other ______
Who obtains informed consent?
Who completes enrollment/ progress notes?
Please use this section to explain any issues with the Informed Consent Process:

5.SUBJECT SELECTION CRITERIA

Review the study files for the subjects you have chosen for review and complete the following. Add additional space as necessary to accommodate the number of chosen subjects.

YES / NO / Reference:
5.1 / Is there an inclusion/exclusion criteria checklist in use? / ICH GCP 5.18.4(i)
Quality Improvement Recommendation
Is there an inclusion/exclusion criteria checklist for each subject reviewed?
Subject #1
Subject #2
Subject #3
5.2 / Does each record indicate whether the subject was included/excluded appropriately?
Subject #1
Subject #2
Subject #3
5.3 / If NO, was a protocol deviation submitted to the IRB? / ICH GCP 4.5.2 & 4.5.3
5.4 / Does the inclusion/exclusion criteria checklist for each subject include dated signature/initials of the person obtaining the information? / ICH GCP 8.3.14
Subject #1
Subject #2
Subject #3
Please use this section to explain any issues with the Subject Selection Criteria:

6. PROTOCOL COMPLIANCE: CASE REPORT FORM (CRF)/SOURCE DOCUMENTS

Reference: FDA 21CFR312.62; ICH GCP 1.51, 1.52, 4.9.0, 8.3.13, FDA ALCOAC Standards

Review CRF documentation for the subjects you have chosen for review and complete the following. Add additional space as necessary to accommodate the number of chosen subjects.

YES / NO / N/A / Reference:
6.1 / Do you keep a study file for each subject?
6.2 / Are there CRFs?
Are there documents that support data captured in CRFs? / ICH GCP 4.9.1, 4.9.2, 8.3.13, & 8.3.14
6.3 / Are all protocol-required parameters captured in the CRFs/source documents for each subject?
Subject #1
Subject #2
Subject #3
6.4 / Does the CRF/source documentation for each subject include dated signature/initials of the person obtaining the information for each subject?
Subject #1
Subject #2
Subject #3
6.5 / Are changes/cross-outs routinely initialed and dated in subject file (if any)? / ICH GCP 4.9.3 & 8.3.15
6.6 / Was the protocol followed appropriately for each subject? / FDA 21CFR312.62, 110
ICH GCP 4.5
Subject #1
Subject #2
Subject #3
6.7 / Who completes CRFs? / PI Coordinator Co-I Other ______
Please use this section to explain any issues with Protocol Compliance or CRFs/Source Documents:

7. INVESTIGATIONAL PRODUCT ACCOUNTABILITY

Reference: FDA 21CFR312.61, 62, 69; ICH GCP 4.6;

Northwell Health Research Policy GR049: Medications and Investigational New Drugs (IND) used in Clinical Research; Northwell Health Research Policy GR050: Use of Controlled Substances in Research

Complete this section forstudies involving the use of investigational product:

(Note: An investigational product includes drugs and biologics.)

Investigational Product:
IND Number/Exemption (if app):
Name of person who handles the IP:
Contact:
Location:
PI / Pharmacy / Other / N/A / Reference:
7.1 / Who is responsible for drug management and accountability? / ICH GCP 4.1.5, 4.6.1, & 4.6.2
(If different) Who is responsible for ordering/receiving the IP?
YES / NO / Reference:
7.2 / (If applicable) Is the responsible staff listed in the delegation log? / ICH GCP 4.1.5, 4.2.4, 4.6.1, & 4.6.2
Are their required training records on file?
Are they immediately notified of any protocol updates and study status (i.e., current protocol version, IRB approval/renewal letters)?
7.3 / Are there shipping documents and receipt verification? / ICH GCP 4.6.3, 5.13.1, 8.2.15 & 8.3.8
Are there documents for IP quality assurance (e.g., CGMP assurance statement in protocol, IB or sponsor’s letter, Certificate of Analysis or batch release records)?
7.4 / Where is the IP stored?
7.5 / Is the IP stored according to specifications? / ICH GCP 4.6.4, 5.14 & 5.18.4(c)
21 CFR 312.61
Is the IP stored in a secure location with controlled access?
Is compliance with storage conditions documented (e.g. temperature logs) and are those records reliable and appropriate (e.g., temperature recording system calibration and min/max or continuous recording)?
If temperature excursions occurred, were procedures and documentation appropriate?
(If applicable) Is the IP stored to prevent medication errors (e.g., separate storage for research medications, each protocol, each product, each drug strength, each lot, returned/used/expired products, etc.)?
YES / NO / NA / Reference:
7.6 / Is there a central IP accountability record form (e.g. DARF, log)? / ICH GCP 4.6.3, 8.4.1 & 8.3.23
21 CFR 312.57, 21 CFR 312.62
(If applicable)
Are there separate accountability forms (e.g., each location, each lot number, each dosage form, each drug strength, each product) and subject-specific accountability forms?
7.7 / Is the receipt of IP documented in the IP accountability record form? / ICH GCP 4.6.3, 8.4.1, 8.4.2, 8.3.23
21 CFR 312.59
Does the current balance on the IP accountability record form match the physical inventory?
Is IP use for each subject documented in the IP accountability record form?
If so, does each IP dispensing entry (date, subject, dose, etc.) match source documents (e.g., prescription, medication number assignment) and in compliance with the protocol?
(If applicable) are drugs returned from subjects documented in the IP accountability record form?
Is the IP return to the sponsor or local destruction of IP documented in the IP accountability record form?
7.8 / Is there a drug order or prescription for each dispensation on file? / GCP 4.1.5 & 4.6.3
NYS Public Health Law Sec. 21
21 CFR 312.61
Note: In NYS, all outpatient orders should be written on an official NYS Rx form or using a serialized label issued by NYSDOH (if done electronically, should be printed on official paper).
Article 137, Pharmacy; §6810. Prescriptions
NYS Rules Part 29
Are those drug orders or prescriptions written by investigators delegated for the protocol?
7.9 / Is the label for the IP appropriate?
(e.g.,proper identification and safety information,blinded information, investigational drug statement, subject and dispensation-specific information) / 21 CFR 312.6
NYS Regulations of the commissioner of Education Sec. 63.12
Article 137, Pharmacy; §6810. Prescriptions
7.10 / (If applicable)
Are the following documents maintained? / GCP 4.6.3 & 4.7

Randomization chart

Treatment arm and dose assignment

Medication number assignment

Other protocol-specific documents for each dispensation

IP return to sponsor or local disposal records

7.11 / Who prepares and dispenses the IP to the subject?
7.12 / Do they prepare and dispense the drug only after confirming each signed informed consent? / GCP 4.1.5 & 4.8.8
21 CFR 312.61
NYS Rules Part 29
Are they qualified NYS-licensed individuals or do the delegated individuals perform the tasks under licensed individuals’ immediate and personal supervision?
Complete the following section only if the study involves the use of controlled substances:
Controlled Substances / YES / NO / Reference:
7.13 /

Which schedule is the drug?

/ Article 33: NY State Controlled Substances Act
NY State Law Title 10, Part 80 – Rules and Regulations on Controlled Substances
21 CFR 312.69
21 CFR Part 1300
Northwell Health Research Policy GR050: Use of Controlled Substances in Research

Does thePI have a current DEA registration for the research protocol on file?

Is a current NYSDOH research license on file?

Are there pertinent CS supply order forms on file (e.g., DEA form 222)?

Are there other required forms on file (e.g., DEA form 106)?

Is reporting to the NYSDOH required?

If so, is this requirement described on the consent form?

Isthe CS stored in compliance with federal and state requirements?

Is access to the CS limited to authorized users (e.g., prescribers or dispensers)?

Are those authorized users listed in the delegation log?

Are the Northwell Health screening forms for the authorized users on file?

(If applicable) Are there any other protocol-specific drug orders by authorized prescriberson file (e.g., for schedule 1)?

Is the CS dispensed by authorized and licensed individuals (e.g., MD, DEA#)?

Is the drug label appropriate (i.e., CS statement)?

Are any unused CS retrieved from subjects?

Iftransported to another location, are the procedures and documentation appropriate?

Are the final disposition procedures and documentation appropriate?

If submitted to the NYSDOH, are there SOPs or other equivalent documents on file?

If so, is the CS handled according to the SOPs?

Please use this section to explain any issues with Investigational Product Accountability:

8.BIOLOGICAL SAMPLING and SHIPPING