To learn the applicable clinical research guidelines, personnel & stakeholders responsibilities, clinical trial study processes, Clinical Data management, Pharmacovigilance etc.
The demand for clinical trials is expected to hit a market value of $64B by 2020 compared to the present value of $38.4B. The market is expected to reflect CAGR at 9% between 2015 and 2020. Currently, ClinicalTrial.gov lists more than 200,000 trials worldwide, creating a number of career options for clinical trial operations and related fields. The Professional Certification in Clinical Research (PCCR) & CDM course allows learners to gain in-depth knowledge of the relevant ICH-GCP and regulatory requirements, clinical trial study methods, duties and responsibilities of various stakeholders, reporting procedures, terminology, etc. This course will allow clinical research candidates and working professionals to succeed in their careers as Clinical Trial Operations Coordinator (CRC), Clinical Research Associate or Clinical Trial Investigators.
|Module 1||Introduction to Clinical Data Management|
|Unit 1||Introduction To Clinical Data Management|
|Module 2||Clinical Data Management|
|Module 3||Medical Coding in Clinical Data|
|Unit 1||Medical Coding And Medical Dictionaries|
|Module 4||Clinical Data Process|
|Unit 1||Data Capture|
|Unit 2||Data Collection|
|Unit 3||Data Validation|
|Unit 4||7. Lab Data Management|
|Unit 5||Query Management|
|Module 5||Case Report Form|
|Unit 1||Electronic Case Report Form|
|Module 6||Quality & Regulatory System|
|Unit 1||Regulatory Systems|
– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.
You can also view our FAQs page for further queries.
Length: 4 weeks
Timings: Self Paced
Effort: 55 hrs. approx
Skill Level: All