patient enrolment process

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.

The procedure for patient enrolment process has been undergone in different

steps.

Patient Database

Pre-screening

Counseling

ICF

ICF Signing

Randomization

Hospital Database

Out patient Database

Laboratory Database

Medical Camps

Referral's from Doctors

Advertisements

Patient Database

Pre-Screening

Disqualified

patients

Prospective

Patients' list

Invited for Participation

Absentees Presenters'

Registration

Counseling

Counseling

Elaborative

counseling Questionnaire

Principle

Investigator

Sub-

Investigator/CRC

Sub-

Investigator/CRC

Informed Consent

Form

Screening ICF

Screening (Inclusion/Exclusion

criteria)

Screen failures Screen pass

ICF signing

ICF signing

Disagree to sign

ICF Agree to sign ICF

Documentation

by PI

Preparation of

source file

Assigning

Enrollment code Randomization

› 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.

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.

Copy of Informed Consent Form is been given to the patient to discuss with the site

staff/ CRC.

ICF is staples with consent Documentation

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.

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.