essentail documents for conduct of a clinical trial

8/6/2019 Essentail Documents for Conduct of a Clinical Trial

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How are Documents Filed?

Before the clinical trialstarts

During theconduct ofThe clinicaltrial

Aftercompletion of the

trial

According to the stage of the trial

Sponsor/CRO

According to the file type

Investigator


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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


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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


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ICH-GCP chapter 8


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GCP Essential Documents forClinical 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


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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


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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)


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Continued

Investigators brochure updates

Revisions to original:

Protocol & amendments

Informed consent form

Case Report Forms (CRFs)

Materials provided to subjects

Advertisements for subject recruitment


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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


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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 casereport form

Examples of source documents include: medical records, labreports, 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


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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


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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


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Records

Regulatory minimum:

The records of all essential documents for drugs have to bemaintained 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 yearsfrom study completion, termination or when records to supportapproval are no longer needed


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During this planning stage the following documents should be

generated and should be on file before the trial formally starts

Before the start of the trial


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Before the clinical phase of the trial commences

Title of document Located in files ofinvestigator

Located in files ofsponsor

Investigators

BrochureX X

Signed protocol and

amendments

X X

Case Report Form(CRF)

X X

Informed ConsentForm

X X

Financial aspect ofthe trial

X X

Insurance statement X

(if required)

X

Source: Roche


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Signed agreement

between involvedparties

X X

Dated, documentedapproval of IRB/IEC

X X

IRB/IEC composition X X

Investigator and sub-investigators curriculum

vitae

X X

Laboratory normalrange and certification

X X

Source: Roche


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Instruction for handlingof investigationalproduct

X X

Investigational productlabel

X

(if required)

X

Decoding proceduresfor blinded trials X X

Randomization list X X

Pre-trial and initiationmonitoring report

Site keeps minutes ofinitiation visit

X

Source: Roche


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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


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During the clinical conduct of the trial



Investigators Brochure(update)

X X

Any revision toprotocol, ICF, CRF etc.and IRB/IEC approval

X X

Update investigators

curriculum vitaeX X

Update laboratorynormal range and

certification

X X

Investigational productlabel for new batch

X

(if required)

X

Source: Roche


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Title of document Located in files ofinvestigator Located in files ofsponsor

Monitoring report X

Relevant

communication

X X

Signed informedconsent forms

X

Source documents X

Signed, dated and

completed CRF

X

(copy)

X

(original)

Documentation ofCRF correction

X(copy)

X(original)

Signature sheet X X

Source: Roche


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Notification of SAEs

and related reports

X X

Interim or annualreports

X X

Subject screening log X X(if required)

Subject enrolment log X

Subject identificationcode list

X

Investigationalproducts accountability

X

Source: Roche


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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


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After completion or termination of the trial



Investigational

products accountability

X

(original)

X

(copy)

Documentation ofInvestigationalproducts destruction

X X

Completed subject

identification code list

X

Audit certificate X

Final trial close outmonitoring report

X

Source: Roche


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After completion or termination of the trial



Treatment allocation

and decodingdocumentation

X

Final report to IRB/EC X X

Clinical study report X X

Source: Roche