Diploma in Clinical Research is a skill development program of 6 months (Full time) duration with a primary focus on Drug discovery and clinical trial processes, Good Clinical Practices (GCP) guidelines, Drug regulatory affairs, Roles and responsibilities of various clinical trial stakeholders. The prime objective is to provide a high-end training thereby enhancing the employment prospects of the participants.

Topics Covered

Module No. Module Title and Components 1 Introduction to Pharmaceutical Medicine • Introduction To Pharmaceutical Industry & Clinical Research • Fundamentals of Anatomy and Physiology • Basic Pharmacology and Pharmacy in Clinical Research • The Drug Development Process • New Drug Discovery • Clinical Development of Drug • Essential Clinical Trial Documents • Clinical Trials Terminology 2 Good Clinical Practice (GCP) Foundations • History of GCP - milestones in the evolution of GCP • Principles of GCP • Applicable GCP Guidelines • Declaration of Helsinki • Clinical Study Process • The Management of Clinical Studies (Sponsor) • Ethics in Clinical Research • Informed Consent • Serious Adverse Event (SAE) • Challenges in the Implementation of GCP Guidelines • Biostatistics in Clinical Research 3 Drug Regulatory Affairs (Clinical Trials) • Overview of Regulatory Environment in USA, Australia, Europe and India • Clinical Trial Application Requirements in India • Import- Export of Clinical Trial Drugs in India • Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. • IND/ANDA/New Drug Application 4 Roles and Responsibilities of Clinical Trial Personnel • Roles and Responsibilities of Sponsor • Roles and Responsibilities of Investigator • Roles and Responsibilities of ERB/IRB/IEC • Roles and Responsibilities of CRA /Monitor • Roles and Responsibilities of Auditor • Roles and Responsibilities of Clinical Research Coordinator or Site Manager • Roles and Responsibilities of CRO's • Roles and Responsibilities of Regulatory Authorities • Roles and Responsibilities of Clinical Data Manager (CDM ) • Roles and Responsibilities of Clinical Biostatistician 5 Roles and Responsibilities of Bio Analytical Personnel • Organization of lab, hierarchy, over all introductions, lab visit • Method development • Overview of mass spectrometry • Overview of HPLC techniques • CC curve and QC samples- preparation use and importance • Extraction methods - theory and practice • Method Validation – Importance and Requirements • Method Validation – Different parameters acceptance and reporting • Regulatory requirements of Method Validation • FDA and EMA guidelines • SOPs preparations, following and deviations • Good Laboratory practice – guidelines and requirements • Good documentation practice • Training on in house forms and log books 6 Hands on training on instruments Training on operation, maintenance and calibration of all equipments/instruments available • pH meter • Balances • Milli Q Water System • Deep freezer • LCMS Systems • SPE chamber • Centrifuge, Cyclo mixer, Vibramax shaker • Sonicator, water bath • Micro pipettes 7 Roles and Responsibilities of Pharmacokinetics Personnel • Introduction, definition, basics of Pharmacokinetics • Design and Evaluation of Bioavailability, Bioequivalence & Phase studies • Study designs – fasting study, food intervention study, multiple-dose (Steady-State) Study, Crossover Designs, Replicated Crossover Design, Evaluation of the data, Pharmacokinetic Evaluation of the data, Statistical evaluation of the data, analysis of variance (ANOVA), Two One sided Test procedure. • Types of clinical trials, design and organization of phase-I, phase-II, phase-III, phase-IV trials • Various regulatory requirements in clinical trials, GCP, Schedule Y, ICMR guidelines etc., • Investigational New Drug application (IND), Abbreviated New Drug Application (ANDA) & New Drug Application (NDA) • Clinical Pharmacokinetics: Introduction to clinical pharmacokinetics, Steady-state pharmacokinetic. Linear and non-linear pharmacokinetics. • Non-compartmental vs compartmental approaches to PK analysis • Clinical Research Methodology – Designing of protocol, CRF, e-CRF, IB, ICF, SOP and BA/BE studies report writing. • Hands on training experience in Kinetica software version 5.1, WiniNonlin software version 6.3 and SAS software version 9.4 8 Roles and Responsibilities of Quality Assurance Personnel • Review of standard operating procedures for Clinic, BA, General, PK and BS • Audit of clinical trials and bio-analytical activities • Audit of facility, lab and clinic as per the regulation and practices • Conducting system and internal quality audit • Review of clinical and analytical reports • Review of DBE, EMA dossier table for regulatory submission • Review of IND,NDA and ANDA submission documentation • Review of study and system specific documents • Review of e-CTD reports for clinic laboratory

Who should attend

• B.Pharm, M.Pharm, Ph.D • M.B.B.S, M.D, M.S, D.N.B, D.M • B.D.S, M.D.S, B.P.T, B.Tech • B.A.M.S, B.H.M.S, B.U.M.S • B.Sc, M.Sc, Ph.D • Working Professionals Final year life science students of above curriculums are also eligible for enrollment in the program.

Pre-requisites

Students should come from the science background

What you need to bring

Candidates are required to send their Application Form along with a copy of highest qualification proof and program fee (through Demand Draft drawn in the favor of “Quest Life Sciences Pvt. Ltd.” payable at Chennai). The candidates are advised to write their name and address on the back of demand draft. The enrollment in Diploma in Clinical Research program is subject to the realization of Program fees.

Key Takeaways

The evaluation is based on the grading of assignments and written examination. The assignments are required to be submitted to the Course Coordinator on or before the scheduled date. Assignments reaching after the scheduled dates will not be considered for the evaluation. Letter grade system is used for grading the assignments and written examination. The letter grades are: A Excellent 80% and above B Very Good ? 60% and < 80% C Good ? 50% and < 60% D Satisfactory ? 40% and < 50% E Unsatisfactory < 40% Candidates securing A, B, C and D grades in the assessments done during the course will receive Diploma in Clinical Research