| Sub Code | Title Of The Paper |
| 101 | Fundamental Of Clinical Research Introduction To Clinical Research -Terminologies -History of clinical research -Drug discovery -In Vivo & amp In Vitro studies Introduction To Preclinical Trial -Types of toxicity studies -CPCSEA guideline Clinical Development -Phase 1 -Phase 2 – subtypes -Phase 3 – subtypes -Phase 4 Bioavailability And Bioequivalence Studies E-Clinical Trial Clinical Trial Essential Documents -Protocol -CRF -IB -SOP’s introduction -Clinical study report -Trial master file & amp e-Trial master file -Clinical Trial logs Investigator Responsibility Sponsor Responsibility Audit & Amp Inspections Clinical Trial Designs |
| 102 | Ethics In Clinical Research And New Drugs And Clinical Trials Rules Background Of Ethics: -Nuremberg code -Declaration of Helsinki -Belmont report -CIOMS guidelines (WHO) Introduction To Ethics Committee -Types of ethics committee -IRB & amp IEC composition -Roles & amp responsibilities Informed Consent Process -Audio-Visual recording of informed consent process -Importance -Elements -Personnel involved -The patient information sheet & informed -Consent form Privacy & Amp Confidentiality In Clinical Research, Compensation In Clinical Research Drug Regulations -History of Indian regulations -Drug & cosmetic Act -1940 -Drug & cosmetic Rules -1945 -New Drugs and Clinical Trials Rules, 2019 -ICMR Guidelines -Indian GCP -ICH GCP -ICH GCP principles -Patent & TRIPS -Drugs & magic remedies Act 1954 -Drug prices control order -Regulations for AYUSH -CTRI-Clinical trial registry of India Regulatory Authorities -USFDA -EMA -DCGI |
| 103 | Role Of Clinical Research Organization, Site Management And Monitoring In CR Outline In Clinical Research CRO -Introduction to CRO -Objectives of CRO -Role of CRO -Role of personnel involved Site Management Organization (SMO) Subject Requirement, Subject Safety. Roles And Responsibilities Of Clinical Research Associate (CRA) Roles And Responsibilities Of (CRC) Roles And Responsibilities Of Sponsor Clinical Trial Monitoring & Types Of Monitoring |
| 104 | Clinical Data Management An Introduction Data Management Standards: -CDISC -21CFR Part 11 -CDMS Systems Setup -CDMS (eg: Oracle Clinical etc.) -What is EDC (e CRF, IVRS, IWRS) -Data management plan -e CRF Designing -e CRF Completion Guidelines -Data Entry Guidelines -Edit check Specification -Data Privacy: Implications for Clinical Operations -User Acceptance Testing Conduct -Date Entry- Double Entry & Single Entry -Data Review & Validation -Discrepancy management -Query Writing -Data clarification form -Data review by using standard reports and J-review -Provided in ORACLE CLINICAL. -Creation of manual checks in J Review. -Medical coding -Last query out -Last Patient Out (LPO)/ Last patient last visit (LPLV) Closeout -Data base lock (Soft lock, Hard lock) -Data storage and archive |
| 105 | Pharmacovigilance -Definition , overview and scope -WHO program for international drug monitoring -UPPSALA Monitoring centre -Signal detection in Pharmacovigilance -Signal generation post marketing surveillance (PMS) -Pharmacovigilance in India -National Pharmacovigilance policy and plan -Pharmacovigilance centres in India -Serious adverse reactions -Applications of pharmacovigilance -Aims and objectives of pharmacovigilance -PSUR |
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