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COVID-19 COVAXINE PHASE-3 CLINICAL TRAIL
Presented by: Presented to:
Kiran Rajput Dr. Nikku Yadav
M.sc Clinical Research Assistant Professor
Department of community medicine
HIMS, jolly grant Dehradun
COVID-19 COVAXINE PHASE-3 CLINICAL TRAIL
INVESTIGATOR SITE
FILE
(ISF/TMF)
TABLE OF CONTENT
1. Investigator Site Fife -Introduction
2. Hands on activity
-Responsibilities and procedure
-Contents of ISF
-Maintenance of the ISF
INVESTIGATOR SITE FILE(ISF)
• The Principal Investigator is responsible for creating and
maintaining the investigator site file. This may be delegated to a
member of the research team and must be reflected on the
delegation of authority log.
WHO IS RESPONSIBLE-
SINGLE SITE STUDY ?
Chief
Investigato
r
Sponsor
Principal
Investigator
CONTENTS OF ISF
PROCEDURE
1. Investigator Site File (ISFs) to be updated in a ongoing
manner and should be always Audit ready
2. All the Essential documents and important correspondences to
be filed in ISFs and CRA will collect copy/original for TMF
during COV.
3. The subject identification log is a confidential record and to be
retained at ISFs ONLY
4. Site to create file note and file it in each respective section
which is not applicable or No document is expected.
RESPONSIBILITIES AND PROCEDURE
Generation of Essential Documents
1.The Principal Investigator (PI) delegates authorship of relevant Essential
Documents to competent and suitably trained members of the trial team.
2.The version of important documents (e.g. protocol, informed consent forms,
case record forms, trial-specific guidelines) should be controlled and contain at
least a trial reference number, version and/or date.
3.Trial-specific forms are developed by reference to the SOPs where relevant.
4.Pre-typed dates and stamps are not acceptable.
MAINTENANCE OF THE ISF
The PI delegates a member of the trial team to verify contents of the ISF before, during and after
completion of the trial. The trial should not start until section 1 has been checked as complete, or
archived until section 3 has been checked as complete. Section 2 will not be dated as new documents
are developed/received.
1.Paper documents will be filed in ISF without undue delay, while electronic copies (scanned
where necessary) will be placed in the allocated trial directory where possible (exceptions may
include signed informed consent forms, source documents, completed CRFs, participant logs
and IP accountability forms).
CONT.…
2. Working copies of documents distributed to members of the trial team should
be managed to ensure outdated versions are replaced when amended or updated.
Outdated copies should be retrieved and destroyed, retaining at least one for
archive.
3. If an essential document is removed from the ISF, a file note is placed in the ISF
stating the purpose of removal and its location.
REFERENCES
• https://www.wwarn.org/tools-resources/procedures/set-and-maintenance-
investigator-site-file
• https://lmkclinicalresearch.com/blogs/investigative-site-files-trial-master-files-
talk/
THANK YOU

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Investigator Site File (ISF) / Trial Master file in trial (TMF)

  • 1. COVID-19 COVAXINE PHASE-3 CLINICAL TRAIL Presented by: Presented to: Kiran Rajput Dr. Nikku Yadav M.sc Clinical Research Assistant Professor Department of community medicine HIMS, jolly grant Dehradun COVID-19 COVAXINE PHASE-3 CLINICAL TRAIL INVESTIGATOR SITE FILE (ISF/TMF)
  • 2. TABLE OF CONTENT 1. Investigator Site Fife -Introduction 2. Hands on activity -Responsibilities and procedure -Contents of ISF -Maintenance of the ISF
  • 3. INVESTIGATOR SITE FILE(ISF) • The Principal Investigator is responsible for creating and maintaining the investigator site file. This may be delegated to a member of the research team and must be reflected on the delegation of authority log.
  • 4. WHO IS RESPONSIBLE- SINGLE SITE STUDY ? Chief Investigato r Sponsor Principal Investigator
  • 6.
  • 7.
  • 8.
  • 9. PROCEDURE 1. Investigator Site File (ISFs) to be updated in a ongoing manner and should be always Audit ready 2. All the Essential documents and important correspondences to be filed in ISFs and CRA will collect copy/original for TMF during COV. 3. The subject identification log is a confidential record and to be retained at ISFs ONLY 4. Site to create file note and file it in each respective section which is not applicable or No document is expected.
  • 10. RESPONSIBILITIES AND PROCEDURE Generation of Essential Documents 1.The Principal Investigator (PI) delegates authorship of relevant Essential Documents to competent and suitably trained members of the trial team. 2.The version of important documents (e.g. protocol, informed consent forms, case record forms, trial-specific guidelines) should be controlled and contain at least a trial reference number, version and/or date. 3.Trial-specific forms are developed by reference to the SOPs where relevant. 4.Pre-typed dates and stamps are not acceptable.
  • 11. MAINTENANCE OF THE ISF The PI delegates a member of the trial team to verify contents of the ISF before, during and after completion of the trial. The trial should not start until section 1 has been checked as complete, or archived until section 3 has been checked as complete. Section 2 will not be dated as new documents are developed/received. 1.Paper documents will be filed in ISF without undue delay, while electronic copies (scanned where necessary) will be placed in the allocated trial directory where possible (exceptions may include signed informed consent forms, source documents, completed CRFs, participant logs and IP accountability forms).
  • 12. CONT.… 2. Working copies of documents distributed to members of the trial team should be managed to ensure outdated versions are replaced when amended or updated. Outdated copies should be retrieved and destroyed, retaining at least one for archive. 3. If an essential document is removed from the ISF, a file note is placed in the ISF stating the purpose of removal and its location.