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Session 21 Practical interpretation of regulatory requirements for documenting the clinical trial for CRAs and CRCs creating the “squeaky clean” file Ruth Ann Nylen, PhD. Clinical research = Daily medical practice.

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Session 21Practical interpretation of regulatory requirements fordocumenting the clinical trial for CRAs and CRCs creating the “squeaky clean” fileRuth Ann Nylen, PhD

focus of discussion
Clinical trial documents required for studies to be submitted to regulatory authorities for registration of pharmaceutical products.Focus of Discussion
keys to the clean study file
Key # 1

Establish study files before the study starts.

Keys to the Clean Study File
recommended file set up for sponsors
IND-level Files
  • Protocol Level Files
  • Investigator Level Files
  • Correspondence with Regulatory Agencies
Recommended File Set-up for Sponsors

Sponsor

recommended file set up for investigative sites
Confidential Documents
  • Study Conduct and Supplies
  • Regulatory Document
  • Subject Documents
Recommended File Set-up for Investigative Sites

Investigator

keys to the clean study file8
Key # 2

Generate and maintain an inventory list of all documents for each study.

Keys to the Clean Study File
keys to the clean study file9
Key # 3

Document an activity when it occurs in the study.

Keys to the Clean Study File
keys to the clean study file10
Key # 4

Review or proof read all documents for accuracy

at the time each is prepared.

Keys to the Clean Study File
keys to the clean study file11
Key # 5

Inventory documents regularly throughout a study.

Keys to the Clean Study File
keys to the clean study file12
Key # 6

Address and resolve document problems immediately.

Keys to the Clean Study File
keys to the clean study file13
Key # 7

Inventory and archive all study documents at study end.

Keys to the Clean Study File
the best list of study documents
The ICH (International Conference on Harmonization) Good Clinical Practice Guideline, Part 8:
  • “Essential Documents for the Conduct of a Clinical Trial”
  • Published in the Federal Register May 9, 1997
  • Available at www.ich.org
The Best List of Study Documents
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8.2.3 Information given to trial subject –Informed consent form –Any other written information–Advertisements (not in sponsor)

Investigator

Sponsor

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8.2.6 Signed agreement between involved parties, e.g., –Investigator/Institution and sponsor –Investigator/institution and CRO (sponsor is only where required)–Sponsor and CRO –Investigator/institution and authority(ies) (Where required)

Investigator

Sponsor

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8.2.7 Dated, documented approval/favorable opinion of IRB/IEC of the following:–Protocol and any amendments–CRF (if applicable)–Informed consent form(s)–Any other written information to be provided to the subject(s)–Advertisement for subject recruitment (if used)–Subject compensation (if any)–Any other documents given approval/favorable opinion

Investigator

Sponsor

8 2 8 institutional review board independent ethics committee composition
8.2.8 Institutional review board/independent ethics committee composition

Where required

Investigator

Sponsor

8 2 9 regulatory authority ies authorization approval notification of protocol
8.2.9 Regulatory authority(ies) authorization/approval/notification of protocol

Where required

Investigator

Sponsor

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8.2.10 Curriculum vitae and/or other relevant documents evidencing qualifications of investigator(s) and sub-investigators

Investigator

Sponsor

8 2 11 normal value s range s for medical laboratory technical procedure s and or test s
8.2.11 Normal value(s)/range(s) for medical/laboratory/technical procedure(s) and/or test(s)

Investigator

Sponsor

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8.2.12 Medical/laboratory/ technical procedures/tests–Certification or –Accreditation or –Established quality control and/or external quality assessment or–Other validation Where required

Investigator

Sponsor

8 2 13 sample of label s attached to investigational product container s
8.2.13 Sample of label(s) attached to investigational product container(s)

Investigator

Sponsor

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8.2.14 Instructions for handing of investigational product(s) and trial-related materials (if not included in protocol or Investigator’s Brochure)

Investigator

Sponsor

8 2 15 shipping records for investigational product s and trial related materials
8.2.15 Shipping records for investigational product(s) and trial-related materials

Investigator

Sponsor

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8.3.2 Any revisions to: –Protocol/amendment(s) and CRF–Informed consent form–Any other written information provided to subjects–Advertisement for subject recruitment (if used)

Investigator

Sponsor

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8.3.3 Dated, documented approval/favorable opinion of (IRB)/(IEC) of the following:–Protocol amendment(s)–Revision(s) of: Informed consent form Written information to be provided to the subject Advertisement for subject recruitment (if used) –Any other documents given approval/favorable opinion–Continuing review of trial

Investigator

Sponsor

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8.3.4 Regulatory authority(ies) authorizations/approvals or notifications where required for:Protocol amendment(s) and other documents

Investigator

Sponsor

8 3 5 curriculum vitae for new investigator s and or subinvestigators
8.3.5 Curriculum vitae for new investigator(s) and/or subinvestigators

Investigator

Sponsor

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8.3.6 Updates to normal value(s)/range(s) for medical laboratory/technical procedure(s)/test(s) included in the protocol

Investigator

Sponsor

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8.3.7 Updates of medical/laboratory/technical procedures or tests–Certification or accreditation or established quality control and/or external quality assessment or–Other validation (where required)

Where required

Investigator

Sponsor

8 3 8 documentation of investigational product s and trial related materials shipment
8.3.8 Documentation of investigational product(s) and trial-related materials shipment

Investigator

Sponsor

slide45
8.3.11 Relevant communications other than site visits –Letters –Meeting notes–Notes of telephone calls

Investigator

Sponsor

8 3 14 signed dated and completed case report forms crfs
8.3.14 Signed, dated, and completed case report forms (CRFs)

Original

Copy

Investigator

Sponsor

8 3 15 documentation of crf corrections
8.3.15 Documentation of CRF corrections

Original

Copy

Investigator

Sponsor

slide50
8.3.16 Notification by originating investigator to sponsor of serious adverse events and related reports

Investigator

Sponsor

slide51

8.3.17 Notification by sponsor and/or investigator, where applicable, to regulatory authority(ies) and IRB(s)/ IEC(s) of unexpected serious adverse drug reactions and other safety information

Where required

Investigator

Sponsor

8 3 18 notification by sponsor to investigators of safety information
8.3.18 Notification by sponsor to investigators of safety information

Investigator

Sponsor

8 3 19 interim or annual reports to irb iec and authority ies
8.3.19 Interim or annual reports to IRB/IEC and authority(ies)

Where required

Investigator

Sponsor

8 3 20 subject screening log
8.3.20 Subject screening log

Where required

Investigator

Sponsor

8 3 24 signature sheet
8.3.24 Signature sheet

Investigator

Sponsor

8 4 2 documentation of investigational product s
8.4.2 Documentation of investigational product(s)

If destroyed at site

Investigator

Sponsor

slide66
8.4.7 Final report by investigator/institution to IRB/IEC where required, and where applicable, to the regulatory authority(ies)

Investigator

8 4 8 clinical study report
8.4.8 Clinical study report

If applicable

Investigator

Sponsor

summary and conclusions
Know the documentation requirements
  • Develop a documentation attitude
  • Accept the Responsibility to Document
Summary and Conclusions