Patient Enrolment Process

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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.

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Patient Enrolment Process

  1. 1.  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.
  2. 2.  The procedure for patient enrolment process has been undergone in different steps.
  3. 3.  Patient Database Pre-screening Counseling ICF ICF Signing Randomization
  4. 4.  Hospital Database Out patient Database Laboratory Database Medical Camps Referrals from Doctors Advertisements
  5. 5. Patient Database Pre-ScreeningDisqualified Prospective patients Patients list
  6. 6. Invited for ParticipationAbsentees Presenters Registration Counseling
  7. 7. Counseling Elaborative Questionnaire counseling Sub- Principle Sub-Investigator/CRC Investigator Investigator/CRC Informed Consent Form
  8. 8. Screening ICF Screening (Inclusion/Exclusion criteria)Screen failures Screen pass ICF signing
  9. 9. ICF signingDisagree to sign Agree to sign ICF ICF Documentation by PI Preparation of source file Assigning Randomization Enrollment code
  10. 10. › 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.
  11. 11.  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.
  12. 12.  Copy of Informed Consent Form is been given to the patient to discuss with the site staff/ CRC. ICF is staples with consent Documentation
  13. 13.  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.
  14. 14.  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.

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