ACH Clinical Study Documents Print01

Wijittra NatthanonworakarnRoche Thailand Ltd.

Essential DocumentsEssential Documents for the Conduct of a Clinical Trial

Clinical Study Clinical Study DocumentsDocuments

What is the Purpose of Essential Documents?

• Individually and collectively permit evaluation of 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

Trial Master Files

• Trial master files should be established at the beginning of the trial.– Sponsor’s FileSponsor’s File– Investigator’s FileInvestigator’s File

• Should be kept in a secure location with limited access

• GCP does not provide a guideline to organize essential documents

• A final close-out of a trial can only be done when the monitor has reviewed both investigator and sponsor files and confirmed that all necessary documents are in the appropriate files.

Hanging file

Sponsor’s FileSponsor’s File

Investigator’s FileInvestigator’s File

• ICH-GCP– A list of essential documents is provided in

Chapter 8 of the ICH-GCP guideline.

• Additional documents required by regulations– Form 1572 (required by US FDA)– Financial disclosure (as Roche form: PD35)

• Defined by Sponsor– Investigational Staff training (e.g. PD33)– Lab Normal Values form (PD24)

Which Documents are Essential?

GCP part 8

Additional documents Additional documents required by regulationsrequired by regulations

– Form 1572 (required by US FDA)

Additional documents required by regulations

– Financial disclosure (as Roche form: PD35)

Additional documents required by regulations

Defined by Sponsor

– Investigational Staff training (e.g. PD33)

Defined by Sponsor

– Lab Normal Values form (PD24)

Defined by Sponsor

The Minimum List of Essential Documents by ICH-GCP

• The various documents are grouped in 3 sections:

BeforeBefore the clinical phase of the trial the clinical phase of the trial commencescommences

DuringDuring the clinical conduct of the trial the clinical conduct of the trial

AfterAfter completion or termination of the completion or termination of the trialtrial

Before the clinical phase of the trial commences

Title of Title of documentdocument

Located in files Located in files of investigatorof investigator

Located in files Located in files of sponsorof sponsor

Investigator’s Brochure

X X

Signed protocol and amendments

X X

Case Report Form (CRF)

X X

Informed Consent Form

X X

Financial aspect of the trial

X X

Insurance statement X(if required)

X





Signed agreement between involved parties

X X

Dated, documented approval of IRB/IEC

X X

IRB/IEC composition X X

Investigator and sub-investigator’s curriculum vitae

X X

Laboratory normal range and certification

X X





Instruction for handling of investigational product

X X

Investigational product label

X (if required)

X

Decoding procedures for blinded trials

X X

Randomization list X X

Pre-trial and initiation monitoring report

Site keeps minutes of initiation visit

X

During the clinical conduct of the trial




Investigator’s Brochure (update)

X X

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

X X

Update investigator’s curriculum vitae

X X

Update laboratory normal range and certification

X X

Investigational product label for new batch

X (if required)

X





Monitoring report X

Relevant communication

X X

Signed informed consent forms

X

Source documents X

Signed, dated and completed CRF

X (copy)

X (original)

Documentation of CRF correction

X (copy)

X (original)

Signature sheet X X





Notification of SAEs and related reports

X X

Interim or annual reports

X X

Subject screening log X X (if required)

Subject enrolment log X

Subject identification code list

X

Investigational products accountability

X

After completion or termination of the trial




Investigational products accountability

X(original)

X(copy)

Documentation of Investigational products destruction

X X

Completed subject identification code list

X

Audit certificate X

Final trial close out monitoring report

X

After completion or termination of the trial




Treatment allocation and decoding documentation

X

Final report to IRB/EC X X

Clinical study report X X

Additional Documents for the FDA studies

• This is for the trial conducted under an IND.

• To be completed before the trial starts FDA 1572 form (Investigator Statement) Financial Disclosure Form

Roche Documentations

• Pre-study visit report (PD20)• Site initiation visit report (PD30)• PD01• Authorization (PD38)• Financial (PD35)• Lab normal value (PD24)• Monitoring report (PD40)• Inventory log• Accountability log• Drug dispensing log• Temperature log• Drug return (PD101)

Roche Documentations

• Document dispatch form (PD52)• CRF dispatch form (PD50)• PD 60 (study close down)• Training form (PD33)• Protocol violation form (PD99)• Database Re-open form (PD80)• Decoding documentation form (PD65)• Safety fax cover sheet (PD55)

The End

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ACH Clinical Study Documents Print01

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