patient enrolment process
DESCRIPTION
Patient Enrolment Process/ICF is essential step in clinical trials. Patients weigh more in clinical trials due to examination of the drug. Patient enrolment is processed based on Inclusion/Exclusion criteria according to the clinical study.TRANSCRIPT
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.