COMIRB #

_ _-_ _ _ _

Drug/Device

Sponsor

Protocol #:

PI:

Volume of __

Regulatory Binder

COMIRB #: _ _-_ _ _ _

Study Drug/Device:

Sponsor Protocol #:

Title:

PI:

TIP Sheet

ESSENTIAL DOCUMENT LIST

Tip #1: Good Clinical Practice
  • IRB approval required for protocol (all versions), informed consent (all versions), SAEs, anything given to the patient
  • NO research activities PRIOR to IRB approval of study and obtaining patient informed consent
  • White out is a NO NO
  • Always line-thru, initial and date errors
  • Train your research team
  • Protect your source documents

Tip #2: Training
  • Document training (delegation of authority log, training logs—site initiation, amendments, letters from the sponsor)
  • Train anyone involved in study: study team (coordinators, data managers, sub-I’s); ancillary departments (lab, Rx, radiology)
  • Have training Standard Operating Procedure (SOP)

Tip #3: Regulatory Binder
  • Tells the story of the study—from first protocol version to completed study
  • Keep all essential documents related to the study (IRB approvals/correspondence; all versions: Protocol, ICF & Investigator’s Brochure , SAEs, Sponsor Correspondence)
  • Have Regulatory Binder SOP—for standardization

Tip #4: Source Documents
  • First place event is recorded, signed and dated
  • Case Report Forms (CRFs) are NOT source documents (data from source docs are entered into CRF)
  • For treatment trials, note Not Clinically Significant (NCS) and Clinically Significant (CS) directly on source document
  • Study-specific, patient-specific source docs should be kept together
  • Utilize highest standards to protect patient health information
  • Save & secure all documents related to the study as per local and federal guidelines (archive)

Tip #5: Serious Adverse Events (SAEs)
  • SAE defined by protocol
  • Must report to: IRB (COMIRB in 5d); Sponsor (24hr) and FDA (15days)

Tip #6: Continuing Review
  • Start collecting continuing review-required data at BEGINNING of study (SAEs, patient demographic info, withdrawal/screen failure numbers, etc.).

For more information, go to or call the Clinical Research Support Center at 720-724-1111 Email:

Clinical Research Support Center

Regulatory Binder

Table of Contents

Section / if not applicable
Protocol
Archived Protocols
Informed Consent Form
Archived Informed Consent Forms
Investigator Brochure
Archived Investigator Brochure
IRB Approval Documents
IRB Submissions
Other Committee Approvals
Adverse Event & Unanticipated Problems Log
Noncompliance Log
External Safety Reports
Notes to File/Waivers
FDA Forms (1571, 1572, 3674, FDA Annual Reports, etc)
Device Accountability Log
Screening Log
Enrollment Log
Delegation Log
Credentials
Site Training Log
Monitor/Audit Reports
Laboratory Certifications (CAP/CLIA; CV of Director; Normal values)
General Correspondence
Study Final Reports

Protocol

(Current approved version with PI signature)

Archived Protocols

(All previously approved versions)

Informed Consent Form

(Current approved, stamped version)

Archived Informed Consent Forms

(All previously approved, stamped versions)

Investigator Brochure

(All versions signed and dated, package inserts)

Archived Investigator Brochure

(All previous versions)

IRB Approval Documents

  • Initial Application
  • Continuing Reviews
  • Amendments

IRB Submissions

(Copies of all documents submitted to the IRB)

IRB Submission Log

COMIRB #:______

Study Title: ______

PI: ______

Submission Type:
1 = protocol amendment
2 = consent revision
3 = personnel change
4 = continuing review
5 = UAP
6 = other (describe
IRB Submission Date: / IRB Approval Date: / Submission Type: / Summary of Changes: / Notes:

Other Committee Approvals

  • SARC
  • CTO
  • UCH Research Support

Services

  • Other

Adverse Event & Unanticipated Problems Log

Adverse Event Definition:

Unanticipated Adverse Device Effect Definition:

Unanticipated Problem Involving Risks to Subjects or Others Definition:

ADVERSE EVENT/UNANTICIPATED PROBLEMLOG

Severity:Causality: Frequency: Outcome: Action taken: Category:Reported to:

1 = mild1 = no relation once resolved 0 = no action 1 = Unanticipated Prob*1 = IRB within 5 days

2 = moderate2 = possibly related intermittent ongoing 1 = study interventionadjusted 2 = AE2 = Sponsor

3 = severe3 = probably related persistent 2 = study interventiondiscontinued 3 = UADE ǂ3 = Lead site

4 = serious4 = definitely related 3 = concomitantmedication taken4 = FDA

5 = IRB at Cont. Review

SUBJECT ID / EVENT DESCRIPTION / START DATE / STOP
DATE / UNANTICIPATED?
(Y/N)* ǂ / SEVERITYǂ / CAUSALITY*ǂ / FREQUENCY / OUTCOME / ACTION TAKEN / CATEGORY / REPORTED TO / PI
INITIAL & DATE

*If unanticipated, possibly/probably/definitely related, andsuggests increased risk of harm, it is an Unanticipated Problem, which must be reported to IRB within 5-10 days of knowledge of event. Refer to COMIRB’s decision tree for guidance (gcrc.ucdenver.edu/comirb/CF-253-Safety-Report-Decision-Tree.pdf.)

ǂ If event is severe or serious, possibly/probably/definitely related to device, and unanticipated, it is an Unanticipated Adverse Device Effect, which must be reported to IRB, and the Sponsor/FDA immediately.

Noncompliance Log

(Protocol Deviations, Protocol Violations, Noncompliance with Regulations, Noncompliance with Requirements of IRB, Noncompliance with Institutional Policy)

COMIRB Safety Report Decision Tree (for help determining which noncompliance needs to be reported and when)

COMIRB Annual Aggregate Protocol Deviation/NonCompliance

Report Form:

External Safety Reports

(MedWatch Reports, IND Safety Reports, Other)

COMIRB Safety Report Decision Tree (for help determining if external report/event needs to be reported)

FDA Forms

As applicable:

  • 1571
  • 1572
  • 3674
  • Financial Disclosure Forms (3454, 3455)
  • FDA Annual Reports
  • FDA Correspondence

Device Accountability Log

  • Keep records for items received,

lost, damaged, destroyed, returned

  • Keep shipping documents for received and sent items

Sample Investigational Device Accountability Log

Protocol #: ______PI: ______

DEVICE RECEIPT / DEVICE USE / DEVICE RETURN/REPAIR/DESTRUCTION
Date Rec’d / Initials of Receiver / Lot #/ Serial or Model # / Device Type / Batch # / Comments / Date Used / Initials of Device Dispenser / Participant ID / Comments / RET=Returned
DES=Destroyed
REP=Repaired / Date / Initials / Auth # / # of Units / Reason / Comments

Screening Log

Study Title:
IRB #
PI:
Subject Identifier (initials or #) / How initial contact with study team made / Initial contact date / Screen Date / Eligible? (Y/N/UD) / If no, reason / Consent Date / Comments
Enrollment Log
Study Title:
IRB #
PI:
Subject Identifier (initials or #) / Consent Date / Copy of ICF to subject (Y/N) / Copy of ICF to medical record (Y/N) / Original ICF to subject research record (Y/N) / Study intervention start date / Study intervention stop date / Subject off study date / Subject withdrawn from study? (Y/N) / Withdrawal reason, if given / Date data collated for Continuing Review

University of Colorado Study Staff Training and Delegation of Duty Log

By signing this log, I certify that I have been trained on this protocol and good clinical practice guidelines.

I understand my role and responsibilities in relation to this clinical trial.

INVESTIGATOR NAME
/
INSTITUTION
/
INVESTIGATIONAL PRODUCT NAME/NUMBER
/
STUDY IDENTIFICATION
/
STUDY SITE
Print Full Name & Title / Signature / Initials /

*Study Role

/ **Key Delegated Study Task(s)
See Examples Listed Below / Duration /

Investigator's Authorization*

From: / To:

*My signature/initials confirms that all responsibilities have been delegated in accordance with recognized institutional practices, state laws and licensure stipulations.

** Identify key study tasks when delegated by the investigator. Examples of key delegated study tasks could include:

1Obtain Informed Consent6Investigational Product Accountability11Regulatory 16Vitals

2Obtain Medical History7CRF Completion12Administer Questionnaires17Phlebotomy

3Perform Physical Exams8 CRF Review and Signature13Assess Adverse Events18PK Draws

4Determine Eligibility 9Data Query Completion14Review Diary Cards19Other______

5Drug Dispensing/Accountability10Data Query Signature15ECG

Credentials

  • CVs
  • Medical Licenses

Site Training Log

  • CITI Training
  • HIPAA Training
  • Protocol Specific Training

Site Training

Protocol Number: ______

Investigator Name: ______

Site Address: ______

______

Study Personnel listed below were trained on the Protocol noted on the Delegation Log.

Training Highlights:

Staff Signature/Date: ______

______

______

______

______

______

Trainer Signature/Date: ______

Staff Training Record

Name: ______Position: ______

Date / Training Description / Employee Signature / Supervisor Signature

Laboratory Certifications

  • CAP/CLIA Certificates
  • CV for Lab Director
  • Normal/Abnormal Value Ranges
  • CLIA waivers with “insert” of instructions
  • Control tests as applicable (i.e. pregnancy test)

General Correspondence

  • All pertinent correspondence to and from site
  • Email
  • Telephone Log

Study Final Reports

  • Study closure report to IRB, FDA
  • Acknowledgement from IRB