The document outlines the patient enrolment process essential for conducting clinical trials, highlighting the importance of informed consent and the steps involved, such as pre-screening, counseling, and randomization. It emphasizes the need for detailed patient education regarding the trial and addresses the patient's autonomy in participating after receiving adequate information. The process ensures that only eligible subjects, based on inclusion/exclusion criteria, are enrolled in the study.

2.  Patient enrolment process plays major role
to conduct clinical trials
 Subject’s are significant in clinical trials
where the new drug evaluation takes
place.
 Patient enrolment process/Informed
consent process has procedure to enroll
subject’s.

3.  The procedure for patient enrolment
process has been undergone in different
steps.

4.  Patient Database
 Pre-screening
 Counseling
 ICF
 ICF Signing
 Randomization

5.  Hospital Database
 Out patient Database
 Laboratory Database
 Medical Camps
 Referral's from Doctors
 Advertisements

6. Patient Database
Pre-Screening
Disqualified Prospective
patients Patients' list

7. Invited for Participation
Absentees Presenters'
Registration
Counseling

8. Counseling
Elaborative
Questionnaire
counseling
Sub- Principle Sub-
Investigator/CRC Investigator Investigator/CRC
Informed Consent
Form

9. Screening ICF
Screening (Inclusion/Exclusion
criteria)
Screen failures Screen pass
ICF signing

10. ICF signing
Disagree to sign
Agree to sign ICF
ICF
Documentation
by PI
Preparation of
source file
Assigning
Randomization
Enrollment code

11. › Assessment of the available information
of the subjects pertaining to the
inclusion/exclusion criteria by an
authorized physician for clinical trial
context without informing to the patient.

12.  Providing information to the patient with all
the aspects of clinical trial.
 Providing education and awareness about
the clinical trial in detail.
 Provide the opportunity to the patient to
raise his/her doubts.
 Investigator is responsible to clarify the
doubts.

13.  Copy of Informed Consent Form is been
given to the patient to discuss with the site
staff/ CRC.
 ICF is staples with consent Documentation

14.  Happens once the elaborative counseling
is done.
 The site staff/CRC should initiate the
questionnaire session before taking patient
to the Principle Investigator.
 It is Mandatory for Investigator before
taking signature from patient on ICF.

15.  Once the counseling and questionnaire
session is done, Patients have their own
choice to take part in the trial. Patient
enrolment is carried out based on
Inclusion/Exclusion criteria. Patient with
inclusion criteria will be taken to the study
by assigning enrolment code and further
proceeded to randomization.