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Research Regulatory File Tabs

  1. Initial submission Forms
    1. Project Submission Transmittal Form
    2. Conflict of Interest Form Drexel University (and Sponsors’ financial disclosure form if applicable)
    3. Advertisement/recruitment materials (if applicable)
    4. Information provided to subjects (if applicable)
    5. Evidence of registration to Clinical Trials. Gov. (if applicable)
  2. IRB approval of Initial submission
  3. Continuing review Submissions
  4. Continuing review IRB approvals
  5. Amendment Submissions
  6. IRB Approvals of Amendments
  7. Reportable new information (Series Adverse Event (SAE)/Unanticipated Problems (UP)/protocol deviation notification to IRB
  8. IRB response to SAE/UP report
  9. Final closure submission
  10. IRB approval of closure (sponsor notification of closure if applicable)
  11. IRB membership/roster (may use note to file) referencing location of the rosters

(A-K) IRB documentation

Requirements

  • Copies of signed and dated materials submitted to the IRB:
    • Initial Application for Human Research
    • Continuing Review(s)
    • Modification(s)/Amendments(s)
    • Reportable New Information form(s)
  • Original IRB notification letters
  • Copy of investigator response to IRB notification (if applicable)
  • Approved/validated recruitment and consent materials
  • Approved/validated additional study information distributed to participants
  • Foreign language materials (if applicable)
  • IRB Membership Roster* containing Drexel University FWA information
  • Additional (significant) correspondence related to the study (e.g. e-mails)
    • Required for FDA-regulated protocols

QA/QI Tips

  • Copies of submissions should be signed and dated.M
  • Approved/validated recruitment materials and additional study information distributed to participants should include version dates and/or numbers.
  • File documents in reverse chronological order (e.g., most recent on top).
  • Request a copy of missing documentation your department-assigned IRB Review Coordinator
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).

Support: GCP: 8.2.7; 8.2.9; 8.3.2; 8.3.3; 8.3.4

  1. All original blank stamped approved consents
    1. All original stamped approved assents (if applicable)
    2. Consent waiver (if applicable)
    3. HIPAA waiver of authorization form (if applicable)
    4. Reference to location of Signed consents: Original signed consents/enrollment log- maintained separate file

(L.) Consent

Requirements

  • Original blank (unsigned) copies of all IRB approved versions of recruitment and consent materials (evident by the IRB approval/validation stamp) with version dates or numbers
  • Copies of foreign language recruitment and consent materials, if applicable

QA/QI Tips

  • Signed and dated consent forms should be maintained separately with enrollment log. A copy of the consent should be placed in participant files.
  • The informed consent process should be documented with a note-to-file or log that confirms:
    1. a discussion took place;
    2. the participant had sufficient time to consider participation;
    3. the participants’ questions were adequately answered;
    4. that the participant voluntarily signed, and
    5. the participant was provided with a copy of signed consent form.
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).

Support: HHS: 45 CFR 46 FDA: 21 CFR 50; 21 CFR 56, GCP: 8.2.3; 8.3.2; 8.3.12

  1. Protocol: each version must be kept on file. With numerous protocols and amendments, recommend placing in separate binder with Note in File tab identifying the location of all protocols

(M.) Protocol

Requirements

  • Original Protocol and all amended versions
  • All versions should contain a version date and/or number

Support: GCP: 8.2.2; 8.3.2

  1. Protocol signature pages; one should exist for each version of the protocol (if applicable)
 
  1. Investigator Brochure (IB): (if applicable)each version must be kept on file. If these are maintained in a separate binder or with the pharmacy binder, reference location of IB in regulatory file)
  2. IB signature page; there must be one for each version of IB. (if applicable)

(O.,P.) Investigator brochure/device manual/package insert

Requirements

  • Most recent version of investigator brochure or product information, e.g., package insert or sample label (for investigational drugs)
  • Device Manual or Report of Prior Investigations, ROPI, (for investigational devices)

QA/QI Tips

  • Send updated versions to the IRB at the time of Continuing Review, unless the update requires a change to protocol.
  • If the investigational product is marketed and its pharmacology is widely understood, a basic product information brochure or package insert is appropriate.
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).

Support: FDA: 21 CFR 312.55, GCP: 8.2.1; 8.3.1

  1. Safety reports (if applicable)

(Q.) Data Safety Monitoring Board/safety reports

Requirements

  • Copy of DSMB Plan
  • Copy of all DSMB reports

Guidance

  • Submit a copy of the most recent DSMB report to the IRB at the time of continuing review
  • Any additional correspondence (e.g. e-mails, letters, meeting minutes) with the DSMB and its members
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).

Support: GCP: 8.3.10; 5.19.3

  1. Evidence of IRB notification of safety reports (if applicable)
 
  1. Sample Case Report Forms( CRF) (data collection instruments)
 
  1. 1571 (if applicable)
 
  1. 1572 (if applicable)
 
  1. Delegation Log/Site signature log
 
  1. Research Team Qualifications;
    1. CV’s Current with first page initialed and dated
    2. Licenses; Current and previous (maintain all on file for duration of study)
    3. Evidence of required research training
    4. Evidence of protocol specific training, initial and continuing with a minimum for each significant protocol amendment

(W: 1.)CVs

Requirements

  • CVs for all study staff

QA/QI Tips

  • If CV unavailable, a bio sketch or resume is an acceptable alternative.
  • CVs should be signed, dated, and updated every 2 years to verify that the information is accurate and current.
  • If CVs are filed collectively for the department, write a signed and dated note-to file indicating the location (include copy of note-to-file here).
  • If CVs are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).

Support: GCP: 4.1.1; 8.2.10; 8.3.5

(W: 2.) Licenses

Requirements

  • Valid licenses/certification for all professional study staff (e.g., medical or nursing license)
  • Current professional certification, as indicated

QA/QI Tips

  • Licensures required only for study staff utilizing their professional license for the study purposes (i.e., if the PI is an MD, no need to include license unless s/he is conducting medical testing, procedures, or exams).
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).
  • In Pa, medical and nursing licenses must be renewed every 2 years. It is important to monitor licensure expiration dates so that those nearing expiration can be promptly replaced.
  • Professional certification information should be included in individual CVs. The frequency with which certification must be renewed varies widely, depending on the requirements of the certifying body

Support: GCP: 4.1.1

(W:4) Training

Requirements

  • Copy of human subjects training certification for all personnel required to complete human subjects training.
  • Additional training certification of study staff, e.g., phlebotomy, vital signs, etc. Any study-specific training documentation for point-of-care testing (pregnancy testing) or study- specific instruments or scales

QA/QI Tips

  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).
  • Any Drexel University affiliate working directly with human subjects, data, or tissue that he or she can link back to individual subjects, must fulfill human subjects training requirements every three years.
  • Anyone (regardless of role) working on a protocol deemed "Not Human Subjects Research" or "Exempt" need not complete training.
  • The Collaborative Institutional Training Initiative (CITI) Program is Drexel University’s online human research training curriculum.

Support: GCP: 8.2.10; 4.1.1

  1. Laboratory: (if applicable)
    1. Current license, certificates (CAP and CLIA) (and previous as long as study is opened)
    2. Director’s CV’s( Current with first page initialed and dated)
    3. Normal ranges for all protocol specific test on file
      -For each central or local lab utilized the above information must be maintained

(X.) Laboratory Documents

Requirements

  • Lab certification (e.g. CLIA, CAP) and updates for clinical labs that are used for diagnosis, treatment, prevention, and/or assessment
  • Lab Director’s current CV for research labs that will not be reporting any Participant-specific results for diagnosis, treatment, prevention, and/or assessment
  • Handling Instructions (if not specified in Investigator’s Brochure, Device Manual, or Package Insert)
  • Normal lab/reference values and updates for clinical labs

QA/QI Tips

  • Keep updated documents to exhibit the competency of all lab facilities being utilized, and to support the reliability of test results.
  • If lab documentation is filed separately, write a signed and dated note to file indicating the location (include note to file here).
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).
  • Research labs typically do not have lab certifications, e.g., CLIA, CAP, and may not have “normal”
    lab values. If research labs are used, ensure that the lab director’s CV and research lab references values are on file.

Support: GCP: 8.2.11; 8.2.12; 8.2.14; 8.3.6; 8.3.7

  1. Investigational product (if applicable)
    1. Instructions for handling /dispensing/administration of product
    2. Shipping records/accountability records for product
    3. Product loss or destruction records (if applicable)
    4. Storage Temperature Log (if applicable)
    5. Subject assignment/accountability record

(Y.) Investigational Product (Device/Drug)

Requirements

  • Drug/device shipment, receipt, return, and destruction records
  • Drug/device Accountability Log
  • Drug/Device Dispensing Log

QA/QI Tips

  • If applicable, write a signed and dated note-to-file indicating where documentation is kept (e.g. Research Pharmacy). Include the note-to-file here.
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).
  • The PI is responsible for the following with respect to investigational drugs/devices:
    • Maintaining records of investigational product delivery to the study site. Include dates, quantities received, batch/serial numbers, and expiration dates.
    • Maintaining an inventory of the investigational product at any site. Inventory control records should be updated, signed, and dated by the PI in a timely manner.
    • Recording/tracking use of the investigational product by each participant. Documentation should verify that dosing/device use was in accordance with the approved protocol. Maintain an accountability log that records when the participant(s) received the drugs/device and the specific dosage/device the participant(s) received.
    • Returning/disposing of unused investigational product as specified by the sponsor. Maintain documentation of return/disposal.
    • Storing the investigational product. The storage area should be locked/secure with access limited to approved study staff only. Drugs/devices should not be stored with standard clinical inventory.

Support: FDA: 21 CFR 312.57; 312.62; 812.140

  1. Monitoring reports (if applicable)
    1. Log of monitor visits
    2. Monitor reports from each visit
    3. Actions in response to monitor reports
    1. Equipment management; (if applicable)
      1. List of equipment provided by sponsor/study specific
      2. Accountability of equipment and evidence of return to sponsor upon completion of trial.
    2. University Guidelines. The Policies and Procedures Manual for medical and non-medical IRBs must be kept in this section. If your project is non-medical, down load the non-medical guidelines or if it is medical, down load the medical guidelines from the Office of Research Website www.research.drexel.edu.
    3. Collaborative or site agreements (letters from schools/other facilities) and approval letters from outside IRBs if the project has been reviewed by another IRB (if applicable)
    4. Research Proposal/Narrative Portions of the grant application such as the hypothesis, purpose, specific aims, experimental methods and analysis or Masters or Doctoral research proposal, NIH grant information
    5. Publication (if applicable)
    6. Communication
      1. Research Team/internal
      2. Sponsor (if applicable)
      3. IRB
      4. NIH grant information/communication (if applicable)
      5. FDA communication (if applicable)
        Each of these can be broken done into emails/faxes/newsletters/telephone logs pending the needs of the study.
 

Subject Chart file (separate)

  1. Consent:
    1. Copy of original and documentation of consenting process (include the subject receiving a copy of consent)
    2. Copy of signed –re-consents and documentation of re-consenting process(include the subject receiving a copy of consent)
  2. Inclusion/exclusion criteria checklist
    1. Support documentation (or reference to location of support documentation) for above criteria
  3. Investigational product: (if applicable)
    1. Logs of product codes associated with subject
    2. Documentation IP is administered/applied per protocol
  4. Study Data/Source Documentation
    1. CRF with source documents or Reference to eCRF and location of source documents
    2. Documentation confirmed for final storage of records
  5. Unanticipated Events: Adverse Events/Series Adverse Events/Protocol Deviations
    1. Events documented and reported per regulatory guidelines
  6. Sample/specimen storage and shipment logs (if applicable)

(A.L;4,V, W:3,W:4,.Z:1.) Logs

Examples

  • IRB Submission Log
  • Enrollment Log
  • taff Signature Log and Delegation of Responsibility Log
  • Participant ID Log
  • Study Monitoring/Visit Log*
  • Reportable New information/Unanticipated Event/Adverse Event Tracking Log/Protocol
  • Deviation
  • Participant Payment Form
  • Human Research Training Log
  • Other
    *Required for FDA-regulated protocols

QA/QI Tips

  • Clinical research Group “Study Management Tools” tab for available template logs and record keeping tools.
  • Update logs in a timely manner. To ensure accuracy, logs should be updated as soon as possible after a recordable event occurs, preferable on the same day.
  • Master enrollment logs that contain identifiable information, which can be linked to individual participants/participant codes, should be stored in a secured location with restricted access to only appropriate study staff.
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).
 

(f.2;) Communication; NIH

Requirements

  • Copy of the NIH grant application and progress report(s)

Guidance

  • Submit a copy of the most recent progress report to the IRB at the time of continuing review.
  • Include here any additional study correspondence (e.g. e-mails) with the NIH and Collaborators.
  • If documents are maintained electronically, write a note-to-file indicating the location and who maintains them (include copy of note-to-file here).

Support: GCP: 8.3.11