Essentail Documents For Conduct of A Clinical Trial

Essential documents for conduct of a clinical trial
CRAA
Purpose of essential documents

To evaluate the conduct of a trial and the quality of the data produced. Demonstrate the compliance of the investigator, sponsor and monitor with GCP and other Applicable Regulatory Requirement. Confirm the validity of the trial conduct and the integrity of data
Become part of a submission to Health Authority To assist in the successful management of a trial by the investigator, sponsor and monitor
Source: Roche
How are Documents Filed?
According to the stage of the trial

Before the clinical trial starts
According to the file type
Investigator
Sponsor/CRO
After completion of the trial
During the conduct of The clinical trial
Trial master file (TMF)
TMF should be filed at the beginning of the trial.

It should be present at both the sponsors site and the trial site
Essential documents
Chapter 8 in ICH-GCP provides a list of essential documents required in a trial
The additional documents required are the 1572 form and financial disclosure form Sponsor defined documents; Training manuals Laboratory normal values
ICH-GCP chapter 8
GCP Essential Documents for Clinical Trials

Investigators Brochure Signed protocol and amendments and sample CRF Information given to trial subjects
Informed Consent including translations All written information Advertisement for recruitment
Financial documents / agreements Insurance statement (if required)
Signed agreements between all involved parties:

Investigator Institution Sponsor CRO Regulatory authorities (where required)
Keep all versions of these documents during the trial
Continued
Dated & approved IRB documents Dated & approved Protocol and amendments Dated & approved Case Report Forms (when applicable) Informed consent forms All other written information provided to subjects Advertisements for subject recruitment Subject Compensation (if any) Other documents approved by IRB
IRB review board and ethics committee composition Regulatory authorization (where required) Curriculum Vitae of investigators and sub investigators - Updated, signed and dated every 2 years Normal value ranges for laboratory tests
Continued.
Lab certifications and accreditations - if required Certifications QA/QC assessment Other validation as required
Shipping and receiving records for investigational products Decoding procedures for blinded trials Master randomization list Trial initiation monitoring report (if applicable)
Continued
Investigators brochure updates Revisions to original: Protocol & amendments Informed consent form Case Report Forms (CRFs) Materials provided to subjects Advertisements for subject recruitment
Continued
Regulatory authorizations and approvals Curriculum Vitae for new investigators or sub-investigators Signed, dated and updated every 2 years Updates to lab values/certifications Investigational product and trial related materials shipment and receipt
Continued..
Correspondence / Communications Letters, meeting notes, notes of telephone calls and emails Signed Informed Consent Forms Source Documents Documents in which data collected for a clinical trial is first recorded, these data are usually later entered in the case report form Examples of source documents include: medical records, lab reports, subject diaries, x-rays, ECG printouts Signed, dated and completed case report forms (CRFs) The Case Report Form is the tool used to collect data from the study. Copies of CRF corrections
Source: ibpa.org
Continued
Adverse Event reports Unexpected and Serious Adverse Event Reports Safety information notifications Interim or Annual reports to IRB and authorities Subject Screening Log Subject Identification code list Subject enrollment log
Source: ibpa.org
Continued
Drug / device accountability log Site signature / delegation of duties log Record of retained body fluids and tissues Completed drug / device accountability log Documentation of return or destruction of investigational product Completed subject identification code list Final report by investigator Clinical study report
Source: ibpa.org
Records
Regulatory minimum: The records of all essential documents for drugs have to be maintained for 2 years from the date of application to market (whether approved or not)
The records for medical devices have to be maintained for 2 years from study completion, termination or when records to support approval are no longer needed
Before the start of the trial
During this planning stage the following documents should be generated and should be on file before the trial formally starts
Before the clinical phase of the trial commences

Title of document Located in files of investigator X Located in files of sponsor X
Investigators Brochure
Signed protocol and amendments Case Report Form (CRF)

Informed Consent Form
X X
X
X X
X
Financial aspect of the trial

Insurance statement
X
X (if required)
X
X
Source: Roche
Title of document
Located in files of investigator X
Located in files of sponsor X
Signed agreement between involved parties Dated, documented approval of IRB/IEC IRB/IEC composition Investigator and subinvestigators curriculum vitae Laboratory normal range and certification
X X X
X X X
Source: Roche
Title of document
Located in files of investigator X
Instruction for handling of investigational product Investigational product label

Decoding procedures for blinded trials Randomization list Pre-trial and initiation monitoring report
X (if required)
X X Site keeps minutes of initiation visit
X
X X X
Source: Roche
During the conduct of the trial
In addition to having on file the above documents, the following documents should be kept on file as evidence that all new relevant information is documented as it becomes available
During the clinical conduct of the trial Title of document Located in files of investigator X
X

X
Investigators Brochure (update)

Any revision to protocol, ICF, CRF etc. and IRB/IEC approval Update investigators curriculum vitae Update laboratory normal range and certification Investigational product label for new batch
X X
X X
X (if required)
Source: Roche
During the clinical conduct of the trial

Title of document Located in files of investigator Located in files of sponsor X X X
Monitoring report Relevant communication
Signed informed consent forms Source documents Signed, dated and completed CRF
Documentation of CRF correction
X X X (copy)
X (copy)
X (original)
X (original)
Signature sheet
X
Source: Roche
During the clinical conduct of the trial Title of document Located in files of investigator X Located in files of sponsor X
Notification of SAEs and related reports
Interim or annual reports

Subject screening log Subject enrolment log Subject identification code list
X
X X X
X
X (if required)
Investigational products accountability
X
Source: Roche
After completion of the trial

After completion or termination of the trial, all of the documents identified in the above tables should be in the file together with the following
After completion or termination of the trial Title of document Located in files of investigator X (original) Located in files of sponsor X (copy)
Investigational products accountability
Documentation of Investigational products destruction Completed subject identification code list

Audit certificate
X
X
Final trial close out monitoring report
Source: Roche
After completion or termination of the trial Title of document Located in files of investigator Located in files of sponsor X
Treatment allocation and decoding documentation Final report to IRB/EC Clinical study report X X
X X
Source: Roche

Essentail Documents For Conduct of A Clinical Trial

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Essential documents for conduct of a clinical trial

Purpose of essential documents

How are Documents Filed?

According to the stage of the trial

According to the file type

After completion of the trial

During the conduct of The clinical trial

Trial master file (TMF)

TMF should be filed at the beginning of the trial.

GCP Essential Documents for Clinical Trials

Financial documents / agreements Insurance statement (if required)

Signed agreements between all involved parties:

Before the start of the trial

Before the clinical phase of the trial commences

Signed protocol and amendments Case Report Form (CRF)

Financial aspect of the trial

Before the clinical phase of the trial commences

Located in files of investigator X

Located in files of sponsor X

Before the clinical phase of the trial commences

Located in files of investigator X

Located in files of sponsor X

Instruction for handling of investigational product Investigational product label

During the conduct of the trial

Located in files of sponsor X

Investigators Brochure (update)

During the clinical conduct of the trial

Monitoring report Relevant communication

Notification of SAEs and related reports

Interim or annual reports

Investigational products accountability

After completion of the trial

Investigational products accountability

Documentation of Investigational products destruction Completed subject identification code list

Final trial close out monitoring report

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