Audio video consenting process and role of CRC or PI during av consenting

1. Presented by-
JAGRITI1

2. As per the DCGI office order dated 19th November 2013, Audio
Visual (AV) recording of the informed consent process has
been made mandatory for regulatory clinical trials following
the Supreme Court order dated 21st Oct 2013.
Requirements For AV Consenting:
1. Approved Protocol by EC and other Regulatory Authority
2. Approved Informed Consent Form & A V Consent Form (Preferred
Languages)
3. Subject
4. Principal Investigator
5. Video Camera
6. Room free from disturbance
7. Well Lit
8. Ensure Privacy and Confidentiality of Patient
9. CD/Hard Disk for storage of AV Records
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3. A V Consenting Process
Approved Protocol
& ICF By EC and
other Authorities
Medically Qualified PI &
Sub-I & Study Coordinator
Selection of the Eligible
Patient who meet the
Inclusion & Exclusion
Criteria
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4. PI, Subject, LAR/IW, Should
be properly captured in video
camera
Introduction of PI,
Subject , LAR/IW and
about the protocol Title.
PI should thoroughly explain all the
elements of the approved ICF including
research, risk & benefits and
Confidentiality of records in the language
best understood by the potential
Subject.
The Subject should be given a proper
time to read the consent document .
A V Consent form should voluntalary signed by the patient before AV Consenting
Process
Starting of AV
Consenting Time
Should Be Noted
(00:00).
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5. If Subject agrees to participate in
the trial, she/he should be asked
questions to assess her/his
understanding of the informed
consent process.
The Subject, LAR/IW (wherever
applicable) should be invited to sign and
read out all the statements mentioned
in ICF and state whether she/he agrees
or not for each statement and affix
signature at the end voluntarily .
THE RECORDING WILL BE STOPPED AFTER THANKING THE SUBJECT.
PI will also sign and date the consent
form at the end of the process.
Store the AV Records of per subject in CD/DVD and in Hard Disk by protecting
Subject Privacy and Confidentiality
Stopping of AV
Consenting process
Time Should also Be
Noted (00:00)
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6. ROLE OF CRC DURING
AV CONSENTING
Role of CRC:
1. Recruiting of eligible Patient by assisting PI/Sub-I.
2. Assurance of Proper Capturing of PI & Patient/LAR/IW during AV Consenting.
3. Insurance of free space from disturbance.
4. Insurance of Proper Light in the AV Consenting Room.
5. Participate in whole process of AV Consenting and assisting with PI/Sub-I.
6. Assuring the ICF is properly signed by the Patient/LAR/IW and PI.
7. Storage and archiving without violating the Patient Privacy and Confidentiality.
8. Insure that Patient Provide his/her consent voluntarily.
9. Assuring AV Consenting Process should be conducted in compliance with Site SOP and
Other applicable guidelines.
A clinical research coordinator (CRC) or the study coordinator is responsible
for conducting clinical trials at clinical trial sites according to the protocol,
ICH-GCP and other regulatory requirements, under the auspices of
the Principal Investigator (PI).
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7. ROLE OF PI DURING
AV CONSENTING
Role of PI…
1. Recruiting the eligible patient.
2. Insure Patient Safety.
3. Explain thoroughly to the patient about the protocol title and research.
4. Explain about the Risk & Benefits involved in research.
5. Read and explain all the points present in ICF Document.
6. Ensure that Subject understand the ICF Properly.
7. Take the subject Consent Voluntarily and signed the ICF at the end to completed the
ICF Process.
8. Storage and Archiving of AV Records to protect the Patient Privacy and Confidentiality.
9. Assuring AV Consenting Process should be conducted in compliance with Site SOP
and Other applicable guidelines.
Principal Investigator is responsible for the conduct of the clinical
trial at a trial site. If a trial is conducted by a team of individuals at
a trial site, the investigator is the responsible leader of the team
and may be called the Principal Investigator.
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8. THANK YOU
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