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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 Guidance related to informed consent process
and documentation to ensure protection of rights, safety and welfare of research subjects.
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
Reference: GCP 4.1.1
Study Personnel Northwell Health Research Policy GR085: Training in the Conduct of Human Subject Research &
GR065: Conflicts of Interest in Research; HRPP Policy Criteria for IRB Approval of Research
6
1) Confirm training
2) Confirm the qualifications of each investigator who is authorized to obtain consent from subjects.
3) 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
YES NO
continuing review?
If yes, was an amendment submitted
YES NO N/A
to the IRB?
Department/ Service Line
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?
If so, what type of regulatory binder is used?
Northwell Health provided version
Northwell Health adapted version ICH GCP 2.10, 4.9.4, 5.5.6, & 5.5.7
1.2
Sponsor provided version
Electronic version
Other: ________________
(If applicable)
Have the study team ensured all electronically
1.3
filed documents are available and easily
retrievable?
Continuing Review # 2
Continuing Review # 3
SAE/AE reports?
Modifications?
Any quality recommendations for the protocol /consent documents?
Please use this section to explain any issues with IRB Documentation:
Reference: ICH GCP 4.8, 4.9, FDA ALCOAC Standards; GR010 Northwell Health Research Policy: Informed
Consent; Northwell Health Policy 100.23 Informed Consent and LEP
List the types of consent forms used
3.1 (e.g. healthy volunteers, affected,
minor or adult subjects, etc.)
Where are the original signed consent Reference:
3.2
forms kept? ICH GCP 8.2.7, 8.3.3 & 8.3.12
Where are copies of the signed consent HRPP Policy: Documentation of Informed
3.3 Consent
forms kept (e.g. MR, subject file, etc.)?
YES NO Reference:
Were any invalid consent forms used? HRPP Policy: Informed Consent
3.4
(Includes use of a consent without an IRB approval
YES NO Reference:
Are there enrollment notes written for each subject
that were signed and dated by individual who wrote
the note?
3.7 HRPP Policy: Informed Consent
If so, is a copy of the enrollment note and consent
form placed in the subject’s inpatient or outpatient
chart (as appropriate)?
Did each subject receive a copy of the signed consent
form? HRPP Policy: Informed Consent
3.8 ICH GCP 4.8.11
Is subject’s receipt of a copy of the signed consent
form documented?
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
HRPP Policy: Informed Consent
3.9 affect their willingness to continue OR when their
status has changed? Quality Improvement Recommendation
(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)
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: