Informed consent documents are required to explain clinical trials to participants and obtain their signed agreement to participate. They must include the study purpose, procedures, risks/benefits, alternatives to participation, and participant rights. Case report forms are used to record all required study data for each participant and facilitate data collection, management, and analysis while protecting privacy. The investigator's brochure provides investigators details on the investigational product and guidance for the study based on nonclinical and clinical data.

1. ESSENTIAL
DOCUMENTS
IN CLINICAL TRAILS

2. INFOMED
CONSENT
DOCUMENTS
CASE
REPORT/RECORD
FORM
INVESIGATORS
BROCHURE
01 02 03
Table Of Contents

3. Informed Consent Documents
It is a legal and ethically obligated written agreement that every
clinical practitioner must provide to potential participants that
explains information such as :
 Purpose of study
 Treatment procedure and schedule
 Potential risks & benefits
 Alternatives to participation
 Individual’s rights as a Subject.
In a language that could be read and understood by the volunteer
and is to be Signed by the volunteer or his/hers legal
representatives, which would indicate that the research participant
has decided to take part in the research of her/his own free will.
It is also known as Informed Consent forms.

4. What ICDs Must Include
According to the World Health Organization's Ethics Review Committee( WHO ERC) template for ICD
The informed consent form consists of two parts: the information sheet and the consent certificate which includes
1.Introduction
2.Purpose of
Study
3.Type of Research
Interventions,
Duration
4.Participant
Selection
Criteria
5.Voluntary
Participation
9.Confidentiality
8. Benefits &
Reimbursement
6.Information on
Trial Drugs
7.Procedure &
Protocol

5. Why Do We Need ICDs
o It informs the participants about the trial and lets them make
educated decisions about taking part in the study.
o Informed consent creates trust between doctor and patient by
ensuring good understanding. It also reduces the risk for both
patient and doctor. With excellent communication about risks and
options, patients can make choices which are best for them and
physicians face less risk of legal action.
o No one can guarantee positive outcomes in healthcare settings, but
informed consent at least ensures patients understand the risks they
undertake with treatment. It is also the law. When patients agree to a
treatment, they must sign paperwork indicating they understand the
risks and agreeing doctors can take specific life-saving measures if
needed.
SEVERE LAPSES IN COVAXIN TRIALS IN BHOPAL, CONSENT FORMS NOT GIVEN;
PARTICIPANTS WHO FELL ILL NOT TREATED
Source: https://www.nationalheraldindia.com/india/severe-lapses-in-covaxin-trials-in-bhopal-consent-
forms-not-given-participants-who-fell-ill-not-treated
Several participants complained they were not informed that they
were participating in COVID-19 vaccine trials. Those who fell ill after
being administered the vaccine were told to pay for treatment
SEVERE LAPSES IN COVAXIN TRIALS IN BHOPAL;
CONSENT FORMS NOT GIVEN, PARTICIPANTS WHO
FELL ILL NOT TREATED
07 Jan 2021, 8:10 AM

6. Why Do We Need ICDs
o It informs the participants about the trial and lets them make
educated decisions about taking part in the study.
o Informed consent creates trust between doctor and patient by
ensuring good understanding. It also reduces the risk for both
patient and doctor. With excellent communication about risks and
options, patients can make choices which are best for them and
physicians face less risk of legal action.
o No one can guarantee positive outcomes in healthcare settings, but
informed consent at least ensures patients understand the risks they
undertake with treatment. It is also the law. When patients agree to a
treatment, they must sign paperwork indicating they understand the
risks and agreeing doctors can take specific life-saving measures if
needed.

7. Case report form (CRF) is a specialized document in clinical
research which could be a printed, optical, or electronic document
designed to record all of the protocol-required information to be
reported to the sponsor on each trial subject.
for accurate input presentation ,verification ,audit and inspection of
the recorded data.
It could be a handwritten one-time snapshot of Participant’s physical
condition or hundreds of pages of electronically captured data
obtained over a period of weeks or months.
Before sending the CRF to sponsor, identification details are
removed, and a unique study number is given to each participant.
Case Report/Record Forms

8. Purpose of CRF
Capturing
all protocol-
required
information
Facilitates
data collection
and entry,
Benefits data
management
and statistical
analysis.
Promote
data sharing
between the
study team
and other
institutions
1
2.
3.

9. The Investigator’s Brochure (IB) is a compilation of the information on
clinical and nonclinical data on the investigational product(s) that are
relevant to the study of the product(s) in methods of administration,
safety monitoring, and human subjects.
Its purpose is to provide the investigators and others involved in the
trial with the information to facilitate their understanding of the
rationale for, and their compliance with, many key features of the
protocol, such as the dose, dose frequency/interval, methods of
administration: and safety monitoring procedures.
It must include information on sponsor’s name and identity of the
product and also the background information on the properties and
history of investigational medicinal product.
Investigator’s Brochure

10. Effects in Humans
Introduction
Physical, Chemical,
And Pharmaceutical
Properties and
Formulation
Summary
Contents Of Investigator’s Brochure
Non-Clinical
Studies
Summary of data
And Guidance for the
Investigator
Confidentiality
Statement

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