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COVID-19 COVAXINE PHASE-3 CLINICAL TRAIL
Source Document
Presented by: Presented to:
Kiran Rajput Dr. NikkuYadav
M.sc Clinical Research Assistant Professor
Department of community medicine
HIMS, jolly grant Dehradun
TABLE OF CONTENTS
1. Source Document-Introduction
2. Purpose of Source Documentation
3. Types of Source Document
4. Principles of good documentation practice
-Source Data
-Source Document
5. Hands On Activity
INTRODUCTION
• Source documentation is the medical record of the subject before,
during and after the trial. It is the tool which confirms the eligibility
criteria of the subject in the given trial. It documents the progress of
the subject from consenting till the subject completes the study.
PURPOSE OF SOURCE DOCUMENTATION
• The most important purpose of source documentation in a clinical trial is to
reconstruct the trial as it happened. It should enable an independent observer
to reconfirm the data. Documentation should be such that it is able to provide
audit trail to permit investigation if and when required.
• Source documentation is the medical record of the subject before, during and
after the trial.
• It documents the progress of the subject from consenting till the subject
completes the study. It records the accountability of the investigational
product dispensed, consumed and returned by the subject.
TYPES OF SOURCE DOCUMENT
• There are Source Documents of 2 types:
i. Electronic
ii. Paper
ELECTRONIC SOURCE DOCUMENTS
• Electronic record means any combination of text, graphics, data,
audio, pictorial, or other information representation in digital form that
is created, modified, maintained, archived, retrieved, or distributed by
a computer system.
• In regards to Electronic Source Documents:
• 1) Requirements to the computer system (validation)
• 2) Requirements to electronic records (audit trail)
• 3) Requirements to electronic signatures
• 4) Requirements to users and technical support
PAPER SOURCE DOCUMENTS
• Handwritten data on the pre-printed forms which have been prepared in
advance
• Handwritten records In both cases the source documents are only the
records, either handwritten or printed out, with the original handwritten
Investigator’s signature.
• The most common type of Source Documentation (SD) is:
official medical documentation, which is used in Medical Institutions on regular
basis:
 Medical History
 Outpatient Medical Chart
 Various Logs / Hospital Charts
PRINCIPLES OF GOOD DOCUMENTATION
PRACTICE
• Any basic training in clinical research will definitely include these phrases:
• ‘What is not documented is not done!’
• ‘Document what is done as well as what is not done!’
• Roots of good documentation principles are in the ICH-GCP where source
data and source document is first defined.
Source data
• All information in original records
and certified copies of original
records of clinical findings,
observations, or other activities in a
clinical trial necessary for the
reconstruction and evaluation of the
trial. Source data are contained in
source documents (original records or
certified copies).
Source documents
• Original documents, data and records
(e.g., hospital records, clinical and
office charts, laboratory notes,
memoranda, subjects’ diaries or
evaluation checklists, pharmacy
dispensing records, recorded data
from automated instruments, copies or
transcriptions certified after
verification as being accurate copies,
microfiches, photographic negatives,
microfilm or magnetic media, X-rays,
subject files, and records kept at the
pharmacy, at the laboratories and at
medico-technical departments
involved in the clinical trial)
Hands On Activity
Visit 1 – Month 0
• At Visit 1 following forms are completed:
1. Date of Visit
2. Informed Consent
3. Demographics
4. Vital Signs
5. Risk Assessment
6. Serology Assessment
7. Urine Pregnancy Tests (for Females)
8. RT-PCR Tests
9. General Examination
10.Systemic Examination
11.Inclusion Exclusion Criteria – If Yes, only then subsequent visits and forms will appear
12.Randomization page – Subsequent visit folders to appear and Vaccination page
13.Post Vaccination – 30 min Post Vaccination – 7 days
14.Subject Diary
References
• 1. Annual report of the GCP Inspectors working Group 2009. Available
from: http://wwwemeaeuropaeu/docs/en_GB/document_library/Annual_repor
t/2010/04/WC500089199pdf. (Assess on 18-05-2021)
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Source Documents Slide Share

  • 1. COVID-19 COVAXINE PHASE-3 CLINICAL TRAIL Source Document Presented by: Presented to: Kiran Rajput Dr. NikkuYadav M.sc Clinical Research Assistant Professor Department of community medicine HIMS, jolly grant Dehradun
  • 2. TABLE OF CONTENTS 1. Source Document-Introduction 2. Purpose of Source Documentation 3. Types of Source Document 4. Principles of good documentation practice -Source Data -Source Document 5. Hands On Activity
  • 3. INTRODUCTION • Source documentation is the medical record of the subject before, during and after the trial. It is the tool which confirms the eligibility criteria of the subject in the given trial. It documents the progress of the subject from consenting till the subject completes the study.
  • 4. PURPOSE OF SOURCE DOCUMENTATION • The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required. • Source documentation is the medical record of the subject before, during and after the trial. • It documents the progress of the subject from consenting till the subject completes the study. It records the accountability of the investigational product dispensed, consumed and returned by the subject.
  • 5. TYPES OF SOURCE DOCUMENT • There are Source Documents of 2 types: i. Electronic ii. Paper
  • 6. ELECTRONIC SOURCE DOCUMENTS • Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. • In regards to Electronic Source Documents: • 1) Requirements to the computer system (validation) • 2) Requirements to electronic records (audit trail) • 3) Requirements to electronic signatures • 4) Requirements to users and technical support
  • 7. PAPER SOURCE DOCUMENTS • Handwritten data on the pre-printed forms which have been prepared in advance • Handwritten records In both cases the source documents are only the records, either handwritten or printed out, with the original handwritten Investigator’s signature. • The most common type of Source Documentation (SD) is: official medical documentation, which is used in Medical Institutions on regular basis:  Medical History  Outpatient Medical Chart  Various Logs / Hospital Charts
  • 8. PRINCIPLES OF GOOD DOCUMENTATION PRACTICE • Any basic training in clinical research will definitely include these phrases: • ‘What is not documented is not done!’ • ‘Document what is done as well as what is not done!’ • Roots of good documentation principles are in the ICH-GCP where source data and source document is first defined.
  • 9. Source data • All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). Source documents • Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, X-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial)
  • 11. Visit 1 – Month 0 • At Visit 1 following forms are completed: 1. Date of Visit 2. Informed Consent 3. Demographics 4. Vital Signs 5. Risk Assessment 6. Serology Assessment 7. Urine Pregnancy Tests (for Females) 8. RT-PCR Tests 9. General Examination 10.Systemic Examination 11.Inclusion Exclusion Criteria – If Yes, only then subsequent visits and forms will appear 12.Randomization page – Subsequent visit folders to appear and Vaccination page 13.Post Vaccination – 30 min Post Vaccination – 7 days 14.Subject Diary
  • 12. References • 1. Annual report of the GCP Inspectors working Group 2009. Available from: http://wwwemeaeuropaeu/docs/en_GB/document_library/Annual_repor t/2010/04/WC500089199pdf. (Assess on 18-05-2021)