Essential documents are critical records and materials that are required for the planning, execution, and reporting of a clinical trial. Essential documents serve as evidence of the trial's progression and adherence to established standards, like Good Clinical Practice (GCP), and applicable regulatory requirements.
Primary function of Essential documents is to validate the trial's compliance with regulatory and ethical requirements, ensure the data accuracy, and facilitate monitoring and inspections by regulatory authorities.
Examples of Essential documents include items such as:
- study protocol,
- Informed Consent Forms,
- Case Report Forms,
- Adverse Event reports,
- regulatory submissions, etc.
Definitions
ICH E6(R2)
ICH E6 1.23, 8.1 Essential Documents:
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements [1].
Purpose
Essential documents should allow a reviewer of trial conduct the capacity to analyze or reconstruct the exact execution of the trial at any point during of after the trial.
List of Essential documents
Per ICH E6 8.1, essential documents are grouped into three sections according to the stage of the trial during which they will normally be generated:
- before commencement of the clinical phase of the trial
- during the clinical conduct of the trial
- after completion or termination of the trial
Documents generated before commencement of a study
Documents pertain to the authorization of the trial by Ethics Committee(s) and Regulatory authority(ies), as well as the setup of trial resources and study personnel.
- Investigator's Brochure
- Signed Protocol and amendments, if any, and sample Case Report Form (CRF)
- Information given to trial subject
- Financial aspects of the trial
- Insurance statement
- Signed agreement between involved parties
- Dated, documented approval/favorable opinion of Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
- Institutional Review Board/Independent Ethics Committee composition
- Regulatory authority(ies) authorization/approval/notification of protocol
- Curriculum Vitae and/or other relevant documents evidencing qualifications of Investigator(s) and Sub-investigator(s)
- Normal value(s)/range(s) for medical/laboratory/technical procedure(s) and/or test(s) included in the protocol
- Medical/laboratory/technical procedures/tests
- Sample of label(s) attached to Investigational Product container(s)
- Instructions for handling of Investigational Product(s) and trial-related materials
- Shipping records for Investigational Product(s) and trial-related materials
- Certificate(s) of analysis of Investigational Product(s) shipped
- Decoding procedures for blinded trials
- Master randomization list
- Pre-trial monitoring report
- Trial initiation monitoring report
Documents generated during conduction of a trial
Documents generated during the conduct of a trial pertain to evidence of the trial's execution.
- Investigator's Brochure updates
- Any revision to:
- Protocol/Amendment(s) and CRF
- Informed Consent Form
- any other written information provided to subjects
- advertisement for subject recruitment
- Dated, documented approval/favorable opinion of Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of the following:
- protocol amendment(s)
- revision(s) of:
- Informed Consent Form
- any other written information to be provided to the subject
- advertisement for subject recruitment
- any other documents given approval/favorable opinion
- continuing review of trial (where required)
- Regulatory authority(ies) authorizations/approvals/notifications where required for:
- protocol amendment(s) and other documents
- Curriculum Vitae for new Investigator(s) and/or Sub-investigator(s)
- Updates to normal value(s)/range(s) for medical/laboratory/technical Procedure(s)/test(s) included in the protocol
- Updates of medical/laboratory/technical procedures/tests
- Documentation of Investigational Product(s) and trial-related materials shipment
- Certificate(s) of analysis for new batches of investigational products
- Monitoring visit reports
- Relevant communications other than site visits
- Signed Informed Consent Forms
- Source documents
- Signed, dated and completed Case Report Forms (CRF)
- Documentation of CRF corrections
- Notification by originating Investigator to Sponsor of Serious Adverse Events and related reports
- Notification by Sponsor and/or Investigator, where applicable, to Regulatory authority(ies) and IRB(s)/IEC(s) of Unexpected Serious Adverse Drug Reactions and of other safety information
- Notification by Sponsor to Investigators of safety information
- Interim or annual reports to IRB/IEC and Authority(ies)
- Subject screening log
- Subject identification code list
- Subject enrolment log
- Investigational Products accountability at the site
- Signature sheet
- Record of retained body fluids/tissue samples (if any)
Documents generated upon completion of a trial
Documents that pertain to the closeout of each site and the study as a whole.
- Investigational Product(s) accountability at site
- Documentation of Investigational Product destruction
- Completed subject identification code list
- Audit certificate (if available)
- Final trial close-out monitoring report
- Treatment allocation and decoding documentation
- Final report by investigator to IRB/IEC where required, and where applicable, to the Regulatory authority(ies)
- Clinical Study Report
See also
Links to this page
- Essential Documents (redirect page) (← links)
- Sub-investigator (← links)
- Certified copy (← links)
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf