Hospital/ SMOs visit which includes visit to laboratories, various departments, radiology department (X-ray and ultrasound), Medical Record Department & Ethics Committee.
Case studies
Training on
Protocol
Informed consent process
Screening procedures
Randomization process(IVRS/IWRS)
Subject retention
Subject scheduled and unscheduled visit
Reporting of SAE/AE
EC Communication
Archival
GCP training
Online GCP training Certificate
Exploring Various Visits
Site Selection Visit
Investigator Meeting
Site Initiation Visit
Monitoring Visit
Audits
Interim
Close Out
CRF Overview
e CRF
RDC
Paper CRF
Handling IP Goods
Drug Receipt & Acknowledgement
Drug Dispensing
Drug Compliance
Drug Reconciliation
Drug Destruction
Handling Lab samples
Processing of Samples
Packaging (Ambient & Frozen)
Source Documentation
IT skill development
Periodic communication and personality development sessions.
INTERNSHIPS
Clinical Research/Trial Internships:
Trainees are professionally trained on the following tasks:-
Primarily they are taught the importance of the ICH-GCP guidelines and its application in the practical environment.
Site preparation for Pre Site Selection Visit.
Conducting Feasibilities
Assisting Principle Investigator at site.
Review, screen and enroll patients.
Order and maintain inventories of drug supplies, lab kits and other documents to support clinical and administrative operations.
Prepare and update medical charts and associated records.
Arrange for prescribed laboratory tests, specialist referrals, and diagnostic procedures.
Maintain the Investigational product in accordance with the protocol procedures and conditions.
Daily record minimum, actual and maximum temperatures of IP in Monitoring temperature log sheets.
Scheduling patient’s visit and study procedures as per protocol.
Managing the day-to-day activities of a study.
Completing and ensuring the quality of Case Report Forms (CRF).
Drug dispensing and accountability.
Ensuring proper documentation in the source document.
Tracking the status of all study activities.
Serving as primary contact with sponsor/CRO/Lab/Vendor.
Submit CIOMS letters to Ethics Committee and report Ethics Committee Acknowledged letters to CRA.
Inform to Ethics Committee and Sponsor within 24 hrs in case of any Adverse Events / Serious Adverse Events occurred in any of the study subjects.
EC communications that includes notifications of the protocol amendment, protocol deviations, investigator brochure etc
Collect, verify record and maintain data on clinical activity and research.
