writing clinical documents 2010

8/9/2019 Writing Clinical Documents 2010

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Whatever Documented is done in clinicalResearch

Document is base for Getting the approval

from Regulatory After approval the product has to launch in to

the market

So document is bases for entering the drug into

the market If anything goes wrong after entering into the

market they( Regulatory) may check previousstudy documents



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A standard for the design, conduct,performance, monitoring, auditing,

recording, analyses, and reporting ofclinical trials that provides assurance thatthe data and reported results are credibleand accurate, and that the rights,

integrity, and confidentiality of trialsubjects are protected.



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All records, in any form (including, but not limitedto, written, electronic, magnetic, and opticalrecords, and scans, x-rays, and electrocardiograms)that describe or record the methods, conduct,

and/or results of a trial, the factors affecting a trial,and the actions taken.

Source Data : All information in original recordsand certified copies of original records of clinicalfindings, observations, or other activities in a

clinical trial necessary for the reconstruction andevaluation of the trial. Source data are contained insource documents (original records or certifiedcopies).



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Document should be concise, Accurate, Legibleand Traceable Records

Concise: The Document must tell the entire storyand understood by the internal/Externalauditors

Accurate: Document must be error free

Legible: Document must be readableTraceable: Each aspects of document must be

traceable such as, who recorded it, where andwhy



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Reports that document what goeson in the clinical setting.

Diagnostic reports

Progress notes

Progress reportsEvaluation reports



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Include all necessary information

Follow proper format

Be clear, concise, and specific Be objective

Focus on the client (Use the clients

name. Do not use first person; if youmust refer to yourself, use thirdperson)



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Clear and Legible

Comprehensive

Accurate

Complete

Confidential



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Report what you

observe, not what youthink!



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1. Investigators brochure

2. Signed Protocol and Amendments, If Any, And SampleCase Report Form (CRF).

3. Informed Consent Form and Patient Information Sheet4. Financial Aspects of the Trial

5. Insurance Statement (where required)

6. Signed Agreement between Involved Parties

7. I RB/IEC Composition8. Regulatory Authority (ies) authorization/Approval/

Notification of Protocol (where required)



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9. Curriculum Vitae And/Or Other Relevant Documents EvidencingQualifications Of Investigator(S) And Sub-Investigator(S)

10. Normal Value(S)/Range(S) For Medical/ Laboratory/Technical

Procedure(S) And/Or Test(S) Included In The Protocol11. Sample of Label (S) Attached to Investigational Product Container

(S)

12. Shipping Records for Investigational Product (S) And Trial-Related Materials

13. Certificate(S) Of Analysis of Investigational Product (S) shipped14. Master Randomization List

15. Trial Initiation Monitoring Report



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1. Investigators brochure Updates2. Any Revision To Protocol and ICD3. Curriculum Vitae for New Investigator(S)

4. Monitoring Visit Reports5. Signed Informed Consent Forms6. Source Documents7. Signed, Dated and Completed CRFs8. Subject Enrolment Log9. IMPs Accountability at the Site10. Signature Sheet11. Subject Identification Code List


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1. IMP (S) Accountability at Site

2. Audit Certificate (if available)

3. Final Trial Close-Out Monitoring Report

4. Final report by investigator to IRB/IEC whererequired, and where applicable, to the regulatoryauthority (IES)

5. Clinical Study Report



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Investigator must ensure the confidentiality of the allinformation related to the patient identity andinformation supplied by the sponsor is respectedby all the persons involved and at all times in

accordance with accepted ethical principals andany confidentiality agreements with the sponsors.The minimum requirements to for documentation to

be stored in conditions that the minimum risk ordamage or loss of information. Documentation

should be located in areas with minimal variationin temperature and relative humidity if stored forlonger period of time.

Minimal Requirements Fire proof, access control



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Can be achieved only through close cooperationCan be achieved only through close cooperationCan be achieved only through close cooperationCan be achieved only through close cooperation


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Avoid RETROSPECTIVE filling.Avoid RETROSPECTIVE filling.



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Can beCan beachievedachieved

only throughonly through

closeclose

cooperationcooperation

Can beCan beachievedachieved

only throughonly through

closeclose

cooperationcooperation



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Risk of data corruption and version conflictRisk of data corruption and version conflicterrorserrors increaseincrease with data transfer operations.with data transfer operations.

CRFs, Source documents, Raw data, Final dataCRFs, Source documents, Raw data, Final datasets, Database design documentation all need tosets, Database design documentation all need to

be preserved.be preserved. Physical security must be guaranteed.Physical security must be guaranteed. Both paper and electronic data are likely to beBoth paper and electronic data are likely to be

stored locally onstored locally on--site as well as centrally. Accesssite as well as centrally. Accesscontrol protocols are essential.control protocols are essential.

Electronic data can be readily backedElectronic data can be readily backed--up toup toappropriate media that can be stored off location.appropriate media that can be stored off location.

Electronic data can be encrypted but open formatElectronic data can be encrypted but open formatstorage has its advantages.storage has its advantages.



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References:

1. ICH E6

2. GDP

3. http://gcp-rma.org/Documents/Retention%20at%20inv%20sites.pdf



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Thank u.


Any doubts?