Enhance Your Skills In The Core Disciplines Of Clinical Investigation.
The NanoDegree in CTPRA is the premier Program for medical professionals who want to want to build a career in clinical research. You’ll gain the skills you need to plan and implement a clinical research program, learn to translate your research into clinical practice, and build a career on the frontiers of health care..
Our CTPRA Skilled NanoDegree course provides you with a strong foundation for research and will complement your professional clinical training. You’ll gain a comprehensive theoretical knowledge of the field, as well as the practical ability to design and evaluate clinical research programmes.
This course is tailored for medical and health professionals who wish to undertake clinical research in their current profession, and for those looking to work in the clinical research industry. Graduates of the NanoDegree will have:
- A comprehensive foundation in the methodologies of clinical research
- A comprehensive understanding of clinical research and issues associated with good clinical practice, ethics and regulations, as well as analytical and project and team management techniques
- High level analytic and problem-solving skills using techniques acquired during the course and independent critical thinking in your field of relevant clinical specialty
- The ability to apply theoretical knowledge in the independent design and implementation of a significant research project
- The ability to write scholarly papers and present their research findings, such as a specialist conference or seminar.
Taught by researchers active in the field of clinical Research, this NanoDegree has a strong research focus, and you will be encouraged to approach empirical research critically.
Through small classes, intense, focused study, and teaching from the best research minds, you’ll graduate with the skills necessary to build your career in Clinical Research – including a detailed understanding of biostatistics, epidemiology, data management, clinical trials, clinical measurement, ethical practice, systematic reviews and meta-analysis, and critical appraisal of the scientific literature for application in research and clinical practice.
You will be taught by an experienced teaching team whose expertise and knowledge are closely matched to the content of the modules on this course. The team includes senior academics and professional practitioners with industry experience. The following group of staff members are currently involved in the delivery of different elements of this course. This pool is subject to change at any time within the academic year.
The course structure and flexibility assists you to extend, integrate and apply your core knowledge and skills with depth across the broad domain of clinical practice and research, something that students want in a highly competitive industry and employers have identified as important.
|S.No.||Subject Code||Title||Module Content||Total Credits|
|1||BSCTPRA 1301||General Introduction to Clinical Research||Basic Introduction to Clinical Research||1|
|Inform consent process||1|
|Avoiding bias and random error data||1|
|Trial Master File||1|
|Bioavalibility and BioEquivalence Studies||1|
|2||BSCTPRA 1302||Basic Pharmacology and Pharmaceutical Medicine||Introduction to Clinical Pharmacology||1|
|Principles of Pharmacology Pharmacokinetics & Pharmacodynamics||2|
|3||BSCTPRA 1303||Guidelines for Clinical Trials (ICH-GCP)||Overview of Good Clinical Practice||1|
|Council for International Organizations of Medical Science (CIOMS) guidelines||1|
|4||BSCTPRA 1304||Drug discovery & Development and Pre-Clinical Studies||Good Laboratory practice||1|
|Narrowing the Gap and understanding Biosimilars||1|
|Introduction to Preclinical studies,Animal Toxicity||1|
|Drug Discovery Development||1|
|5||BSCTPRA 1305||Ethics In Clinical Research||Instititional review of research,Composition of the EC quorum||3|
|Introduction to World Medical Association & Declaration to Helsinki (DOH)||1|
|CPCSEA Guidelines – ethics and handling of laboratory animals||1|
|6||BSCTPRA 1306||Roles And Responsibilities||Heath and Human Services regulations(HHS)||1|
|Roles & Responsibilities of Ethics Committee||2|
|Roles & Responsibilities of Investigator||2|
|Roles & Responsibilities of Clinical Research Coordinator||2|
|Roles & Responsibilities of Sponsor||2|
|Roles & Responsibilities of CRA/Monitor||2|
|Roles & Responsibilities of Auditor||2|
|Roles & Responsibilities of Clinical Data Manager||2|
|Roles & Responsibilities of Clinical Biostatistician||2|
|7||BSCTPRA 1307||Clinical Trial Preparation||Roles & Responsibilities of CROs/SMOs||2|
|Principal of controlled Clinical Trials||2|
|8||BSCTPRA 1308||Essential Documents And Regulatory Submission||Improving Patient enrollment and retention||1|
|New Drug Application(NDA): Pre NDA meeting , NDA submission Check list , FDA NDA review check list||2|
|Investigational New drug (IND): Classifications, IND application submission check list, FDA IND review check list , IND application process, Information for sponsors-investigator submitting IND, IND forms and instructions||2|
|Orphan Drugs Application : Submission check list, FDA orphan drug review check list , FDA documents||2|
|9||BSCTPRA 1309||Study Start-up & Procedures in Clinical Trial||Abbreviated New drug Application(ANDA): ANDA content, ANDA Submission check list , FDA ANDA review check list , ANDA process for generic drugs, guidance documents for ANDAs, ANDA forms and electronic submissions||2|
|Site Initiation Visit (SIV)||1|
|Site Selection Check list||1|
|Site Monitoring Visit (SMV)||1|
|Site Close Visit (ScV)||1|
|10||BSCTPRA 1310||Clinical Trials Documents||Interim Report||1|
|Standard Operating Procedures (SOP) in Clinical Trials||1|
|Clinical Study Report||1|
|11||BSCTPRA 1311||Compliance And Audits||Inspection – staff Responsibility Before,After ,During audit||1|
|Adverse events unanticipated problems||1|
|clinical investigator site inspection||1|
|12||BSCTPRA 1312||Data Management And Biostatistics||clinical trial exemption||1|
|Biostatastics in Clinical Research||2|
|electronic clinical trials||2|
|Hypothesis Testing ,Parametric Test,Probability,Measure of Center Tendancy,Measure of Dispersion,Correlation,Regression,Chi Square Test,T-test||3|
|13||BSCTPRA 1313||Regulatory Affairs In Clinical Research||Query Management and DCF Resolution||1|
|schedule Y for toxicity studies||1|
|Structure and mandate of FDA||1|
|e-CTD (Common Technical Document)||1|
|Drugs Controller General of India (DCGI)/Central Drugs Standard Control Organization (CDSCO) submissions,||2|
|FDA and DCGI Guidelines-Vaccine,Diagnostic and surgical Trials||2|
|14||BSCTPRA 1314||Medical Device Trials||US & UK Regulation of Medical Devices||1|
|Issue in clinical trial design for medical device||1|
|Clinical Evaluation of Medical Devices||1|
|15||BSCTPRA 1315||Project And Vendor Management||2|
|Budgeting of Clinical Trials||1|
|Roles and responsibilities of a Project manager||1|
|Project Management matrix, Business development strategies||1|
|Site Selection Criteria- Site Selection parameters: Location, Staffing, Qualifications, History, Clinical trial experience, Area of therapeutic experience, Investigational pharmacy, ICH-GCP compliance,||2|
|16||BSCTPRA 1316||Pharmacovigilance and reporting Drug Safety||Good Pharmacovigilance Practice (GPP)||1|
|Pharmacovigilance and ICH guideline||1|
|Periodic safety update reports(PSUR) for marketed drugs||1|
|Classification of Adverse Drug Reactions||1|
|Pharmacovigilance in Europe||2|
|Adverse Event reporting form||2|
- Graduate/Post Graduate degree in Pharmacy/ Pharmaceutical Science
- Graduate/Post Graduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology)
- Graduate or Equivalent degree in Nursing/Allied Health
- Students in their Final Year of Graduation for the above courses may also apply.
The minimum time in which a student can complete this diploma course is 06 months while a maximum of 12 months is allowed to complete the course.
Assessment of students will be through continuous assessment of each module, which will include written assignments, team-based assignments, and open-book exams using multiple choices, matching questions as well as short and long answer questions. All the participants are obliged to timely submit completed assessment assignments (during the course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will be awarded Skilled Nano-Degree in CPTRA by BBMInstitute.
After the completion of the NanoDegree Program, a wide array of professional opportunities awaits the students. The NanoDegree CPTRA aims to build research capacity through a formal qualification and improve the quality of the conduct of trials. Leading to employment opportunities in clinical trials research, the NanoDegree is designed to equip graduates with the skills necessary to lead and design clinical trials both nationally and internationally.
- For Doctors: Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician.
- For Paramedics, Pharmacists & Life Science Graduates: Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trail analyst / Drug Reviewer / Drug Safety Physician & many more
- For Management Professionals:(with Life Science/Health Science background) Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs.
- Clinical Research Associates:To monitor clinical trials, ensure compliance with the clinical trial protocol, checks clinical sites activities, make on-site visits, CRFs.
- Clinical Research Investigators:Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
- Study Coordinators:Provides safety & protection while collecting & managing the study data.
- Data Manager / Biostatistician:Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
- Regulatory Affairs Managers:Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
- Clinical Trials Auditors:Conducts audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
- Clinical Research Managers:Manage, supervise, train, mentor clinical research staff, approve investigator’s study, budget & contract, review & approve regulatory documents, develop a protocol, approve CRFs, review study data.
- Business Development Manager:Identify potential clients, establish business relations, responsible for meeting new clients, following up on leads, market research.
- Drug Safety Associate:Manage & relay drug safety information, maintain current knowledge of global drug safety regulations, summarize clinical safety data, write narratives with medical input, report SADRs to Regulatory Authorities, participate in training on drug safety issues & another task under drug safety.
- Medical Writer: Documentation, manuscripts, abstracts, external communication tools Clinical Data Manager: Ensures the accuracy & consistency of data prepared for regulatory bodies for reporting purpose.
- Others: Auditors, Quality Assurance, Patents & IP Related position