Writing regulatory documents for drug approval is a critical process that requires utmost accuracy and clarity. These documents play a vital role in demonstrating the safety, efficacy, and quality of a drug to regulatory authorities such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

1. Welcome
WRITING REGULATORY DOCUMENTS FOR DRUG
APPROVAL:THE IMPORTANCE OF ACCURACY AND
CLARITY
Student Name :Mohammad.saiena
Qualification: Pharm d
Student ID:073/042023
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2. Index
• Regulatory writing
• Regulatory documents
• Importance of documentation
• Procedure for documentation
• Good documentation practice
• conclusion
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3. REGULATORY WRITING
•Involves developing regulatory documents that health authorities requires before the
approval of a new drug, device or biologics.
•Essential documents are commonly referred to as regulatory documents.
•International conference on harmonisation(ICH) good clinical practices(GCP) guidance
defines essential documents as those documents which individually and collectively
permit evaluation of the conduct of the clinical trial and the quality of data produced.
•These documents serve to demonstrate the compliance of the investigator, sponsor and
monitor with the standards of Good Clinical Practice and with all applicable regulatory
requirements.
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4. REGULATORY DOCUMENTS
• Investigator's Brochure (IB)
1. To document that relevant and current scientific information about the
investigational product has been provided to the investigator
2. Typically there is a signature page in the IB that should be signed by the
Principal Investigator (PI) and returned to the study sponsor
• A copy of the IB signature page should be retained
3. When updated IBs are issued, they should be filed accordingly. Outdated IBs
should not be removed from the file.
• FDA Form 1572
To document the agreement of the investigator to provide certain information
to the sponsor and to assure that he/she will comply with FDA regulations related to
the conduct of a clinical investigation of an investigational drug or biologic.
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5. REGULATORY DOCUMENTS
•Delegation of Responsibilities Log
To document the investigator's delegation of certain responsibilities to study personnel in order
to conduct the clinical trial.
•Protocol and Amendments
1. Typically there is a signature page in the protocol/amendment that should be signed by the
Principal Investigator (PI) and returned to the study sponsor
2. A copy of the protocol/amendment signature page should be retained
3. When amendments are issued, they should be filed accordingly. Outdated protocols should not be
removed from the file.
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6. REGULATORY DOCUMENTS
• Information Given to a Study Participant Informed Consent
• To document the informed consent process
• This document must be approved by the IRB before it can be
used
• Other Written Information
• To document that study participants have given their fully
informed consent
• Recruitment Advertisement
• To document that recruitment measures are appropriate and not
coercive
• This document must be approved by the IRB before it can be
used
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7. REGULATORY DOCUMENTS
• Financial Disclosure Form (FDF)
• To document the financial agreement between investigator/institution and the trial
sponsors.
• A FDF must be completed and signed by each investigator. The original must be
returned to the study sponsor and a copy retained
• A new FDF must be completed any time there is a change in the investigator's
financial situation (i.e. stock purchases, etc.)
• Master Clinical Trial Agreement (MCTA)
• To document agreements between the PI/institution and the study sponsor and/or
CRO
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8. REGULATORY DOCUMENTS
• IRB Approval
• To document that the trial has been subject to IRB review approval.
• Approval will be granted for multiple items, including but not limited to:
• Protocol
• Informed consent document
• Recruitment advertisements and other written information to be provided to the study
participant
• Curriculum Vitae (CV)
• To document qualifications and eligibility to conduct trial and/or provide medical supervision of
study participants
• Required for each investigator participating in the research study
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9. REGULATORY DOCUMENTS
• CVs must be current and updated every two years, indicate the investigator's association with the
institution where the research study is being conducted, and display the address noted on the
1572 (when applicable)
• Outdated CV's should not be removed from the file
• Medical Licensure
• To document qualifications and eligibility to conduct trial and/or provide medical supervision of
study participants
• Required for each investigator who is a medical doctor participating in the research study
• Training Records
• To document that study personnel have received adequate study-specific training in order to
execute the protocol.
• Training can include a Site Initiation Visit or Investigator Meeting attendance.
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10. REGULATORY DOCUMENTS
• The training record should reflect appropriate training for all study personnel.
• This can include training on specimen collection, handling, and storage.
• Laboratory Certification or Accreditation
• To document competence of facility to perform required tests and to support the reliability of
results
• Many sponsors require both CAP and CLIA certification; however, this is very sponsor- and
protocol-specific
• Certifications must be current
• Laboratory Normal Values
• To document normal values and/or ranges of the tests
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11. REGULATORY DOCUMENTS
• Monitor Visit Reports
• To document the completed activities and to address any issues noted during a monitor visit.
• Site selection visit(pre trial monitoring) report
• Site Initiation Report or Investigator Meeting attendance record
• Monitoring Visit Reports
• Close-out Visit Report
• Sponsor Correspondence
• To document all correspondence between the study site and sponsor/CRO.
• This should include all email correspondence.
Source Documents
To document the existence of the subject and substantiate integrity of trial data collected.
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12. REGULATORY DOCUMENTS
• Notification of Serious Adverse Events by Investigator to Sponsor
Notification by originating investigator to sponsor of Serious Adverse Events and related reports
• Notification of Serious Adverse Events by Sponsor to Regulatory Authorities
Notification by sponsor and/or investigator to regulatory authorities and IRB of unexpected
serious adverse events
• Subject Screening Log
• To document identification of subjects who entered pre-trial screening
• Subject Identification Log
• To document that investigator/institution keeps a confidential list of names of all subjects
• Allows investigator/institution to reveal identity of any subject
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13. REGULATORY DOCUMENTS
• Signature Sheet
• To document signatures and initials of all personnel participating in the research study
• Investigational Product Accountability Log
• To document that investigational products have been used according to the protocol
• Documentation of Investigational Drug Destruction
• To document destruction of unused investigational products by sponsor or at site
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14. IMPORTANCE OF DOCUMENTATION
• Documentation plays a vital role in clinical research. It validates how authentic the research data
was collected and verify the result of data.
• In clinical research “if is not documented, it is not there”!
• Documentation of the activities in clinical research to ensure the quality.
• In good clinical practice, essential documents individually and collectively permit evaluation of
the conduct of a study and the quality of the data produced.
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15. PROCEDURE FOR DOCUMENTATION
• All documentation entries shall be done with black ink (ball point) and legible handwriting.
• Do not leave any document incomplete. If not applicable write not applicable (NA).
• Do not use correction fluid in any documents.
• All personnel should ensure to avoid error during data entry.
• In case error has occurred. do not overwrites wrong entries, cross with a line permit the reading of
original entry. Clearly write the correct entry near the cross out. initial/sign and put date on which
correction was made.
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16. GOOD DOCUMENTATION PRACTICES
• The FDA uses the acronym ALCOA (attributable, legible, contemporaneous, original, and
accurate) to describe the importance of GDPs. The key to ALCOA is thorough documentation
to ensure reproducibility and traceability.
• Alcoa+
 Attributable means information is captured in the record so that it is uniquely identified as
executed by the originator of the data
• Legible, traceable and permanent.
 The terms legible and traceable and permanent refer to the requirements that data are readable,
understandable, and allow a clear picture of the sequencing of steps or events in the record so
that all gxp activities conducted can be fully reconstructed by the people reviewing these records
at any point during the records retention period set by the applicable gxp.
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17. GOOD DOCUMENTATION PRACTICES
• Contemporaneous data are data recorded at the time they are generated or observed.
• Original data include the first or source capture of data or information and all subsequent data
required to fully reconstruct the conduct of the gxp activity.
• The term “accurate” means data are correct, truthful, complete, valid and reliable.
• Implicit in the above-listed requirements for alcoa are that the records should be complete,
consistent, enduring and available (to emphasize these requirements, this is sometimes referred to
as alcoa-plus).
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18. CONCLUSION
The documentation should tell the entire story and speak for itself for the study
participants journey as it happened to auditor/inspector thus making a complete
picture and forming a strong foundation for clinical research.
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19. REFERENCE
• https://ccts.osu.edu/content/regulatory-documents
• https://www.finenessinstitute.com/why-documentation-is-important-in-clinical-
research/#:~:text=In%20clinical%20research%20%E2%80%9Cif%20is,quality%20
of%20the%20data%20produced
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20. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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