The goal of the QI Program is to continue the Partner's tradition of excellence, to conduct all research involving human subjects according to the highest standards, recognizing that doing so makes us a premier site for clinical research.

Please note, not all sections of the Self-Assessment Checklist may apply to your study. You have the option of completing each section individually or going through the entire checklist. Once you have completed the Self-Assessment Checklist, you can save the document to your local drive and/or print out a hard copy for your records. Members of the QI staff will be available to assist you and to answer any questions you may have.

CHECKLIST CONTENT:

Regulatory Documentation

IRB Documentation

Subject Recruitment Procedures

Subject Selection Criteria

Informed Consent Process

Adverse Event Reporting

Protocol Violations, Deviations, Exceptions

Drug / Device Dispensing Accountability

Data Collection & Source Documents

Record Keeping

Genetic Research

Regulatory Documentation

Regulatory documentation includes the essential documents that individually and collectively permit the evaluation of the conduct of the trial and the quality of the data produced. The QI Program recommends a separate study file or binder in which these documents can be kept. Recommendations as to content and format can also be found by viewing the QI Program's Virtual Regulatory Binder.

Depending on the type of study you are conducting and the study sponsor, different regulatory documents are required. All studies conducted at Partners should comply with Good Clinical Practice (GCP) guidelines and Partners Human Research Committee (PHRC) Institutional Policies. To ensure that your study site is compliant with GCP standards and PHRC policies, complete Section I for all studies.

SECTION I

	YES	NO	N A
Is documentation of Federal Wide Assurance (FWA) number on file? If no, documentation can be found at: http://healthcare.partners.org/phsirb/assure.htm
Are all applicable signed agreements/contracts between parties on file? (e.g. between PI and sponsor; between PI and CRO)
Is the most recent version of the IRB approved protocol on file?
Are all previous versions of the IRB approved protocol on file?
Are copies of most recently approved sample case report forms (CRF) on file?
Are there CVs/biosketches of PI, Co-Is, and all study staff on file?
Are CVs updated within the past two years?
Are CVs signed and dated?
Is there a subject enrollment log?
Is study site monitored?
Is there a monitoring log?
Are copies of site visit (external) monitoring reports on file?
If yes, do monitoring reports include Site Initiation report/visit documentation?
If yes, do monitoring reports include study close-out report/visit documentation?
Are all relevant communications (e.g. meeting notes, letters and emails) with study sponsor on file?
Is there a staff signature log?
Does the study signature log reflect current staff working on the study?
Are all staff working on the study IRB approved?
Does the staff signature log (or other documentation) capture delegation of responsibility?
Are lab tests required?
If yes, is a copy of normal lab values on file?
If yes, is lab certification on file, (e.g. CLIA)?