PG Diploma in Clinical Research

BY
Bangalore Clinical Research Institute

Learn clinical research, data management, trial data analysis, and pharmacovigilance with a PG Diploma in Clinical Research from BCRI

Mode

Online

Duration

7 Months

Quick Facts

particular details
Medium of instructions English
Mode of learning Self study, Campus Based/Physical Classroom
Mode of Delivery Video and Text Based

Course overview

The PG Diploma in Clinical Research certification course duration is 7.5 months. The eligibility criteria to enroll for this certification course is that the students must be graduates or post graduates in life science, pharmacy, and medical fields. The course equips the students to manage patient recruitment, data collection, adverse event monitoring, and protocol adherence.  

Students will gain hands-on training and expertise using EDC software such as Clinevo and Saftey Database. The PG Diploma in Clinical Research certification by BCRI offers a robust curriculum that includes Good Clinical Practice (GCP), ICH guidelines, and local regulations. Students will gain in-depth knowledge of clinical research methodologies, SAPSAS base, and clinical data analysis. 

Also Read: Online Clinical Research Courses & Certifications

The highlights

  • Training Online/Classroom
  • Campus/Free Webinars
  • 100% placement Support 
  • Hands-on Experience 
  • Real-Time Industry Experts

Program offerings

  • Sas training
  • Robust curriculum
  • Covers major domains
  • Expertise in using edc software
  • Clinevo and saftey database

Course and certificate fees

certificate availability

No

Who it is for

The certificate course is designed for aspiring students, and working professionals to develop their skills and knowledge. This course is also beneficial for:

Eligibility criteria

Academic Qualifications

The eligibility criteria to opt for this course is that the students must complete their graduation degree in any of the fields like Science (Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology), Medicine (MBBS, BDS, BPT, BAMS, BHMS, BUMS), Pharmacy or Pharmaceutical Sciences (B.Pharm, Pharm.D).

What you will learn

After completing the PG Diploma in Clinical Research certification syllabus, the students will be able to use the EDC software such as Clinevo and Saftey Database. They will also learn clinical research, clinical data management, clinical SAS, regulatory affairs and pharmacovigilance, and drug safety.  

With the support of industry experts, students will gain skills in clinical data management. Upon the completion of the PG Diploma in Clinical Research training, the participants will gain a deep understanding of case processing, narrative writing, Statistical Analysis Software (SAS).

The syllabus

Clinical Research

  • Overview of Clinical Trials, Phases (0–5), and Study Designs
  • Drug Development Process & IND/NDA Submissions
  • Study Setup: Protocols, CRF Design, SOPs, Ethics Committees
  • Trial Design: Efficacy, Safety, Microdosing, SAD/MAD
  • Trial Documentation: Investigator Brochure, Logs, Visit Forms
  • Quality Assurance, Regulatory Affairs, ICH-GCP, DCGI Guidelines

Clinical Data Management

  • Data Collection, CRF Tracking, and eCRF Setup
  • Database Design, Data Validation Plans, DVS
  • Discrepancy Management, Query Resolution, Audit Trails
  • Tools: RDC, IxRS, CTMS, EDC Validation
  • SAE Reconciliation, Medical Coding, UAT, Lab Data Integration

Pharmacovigilance

  • AE/SAE Identification, Reporting, and Timelines
  • PV Databases, Case Processing, Duplicate Search
  • MedDRA & WHO-DD Coding, Signal Detection
  • DSUR, PSUR, PBRER, Aggregate Reporting
  • Special Case Scenarios: Off-label, Pregnancy, LOE, Errors
  • Regulatory: FDA, EMA, CIOMS, WHO-UMC, CDSCO

Clinical SAS Programming

  • Base SAS: DATA/PROC Steps, Import/Export, Functions
  • Advanced SAS: PROC SQL, Macros, Debugging, Joins
  • CDISC SDTM & ADaM: Mapping, Define.xml, TLF Generation
  • Statistical Analysis: PROC TTEST, ANOVA, GLM, LIFETEST
  • Report Automation using ODS, SAS Macros
  • Regulatory Submission Standards (FDA/EMA Alignment)

Admission details

Students can join the PG Diploma in Clinical Research classes by following the below-mentioned steps: 

Step 1: Browse the link mentioned below:

https://www.bcri.in/pg-diploma-in-clinical-research/

Step 2: Click on the "Enroll and Pay" button

Step 3: Fill in the application form with the required details and submit it.


Filling the form

Once the candidates visit the official course page, they can find "Enroll and Pay" button, click that option fill in the application form with the required details, and submit it.

How it helps

The PG Diploma in Clinical Research certification benefits include:

  • The programme supports the students by providing certified and experienced instructors.
  • The certification course offers an industry-oriented curriculum and live online classes. 
  • Students can attend the classes at their convenience. 
  • The course also offers 100% placement support post-completion of the training.
  • Students will also receive classroom recordings and e-notes to gain a comprehensive understanding of the subject.

FAQs

How long does the PG Diploma in Clinical Research training last?

The duration for this certification course is 7.5 months. The course offers an in-depth knowledge of clinical research and the aspects related to it.

How students can apply for the PG Diploma in Clinical Research certification course?

Students must visit the official course page, click on the "Enroll and Pay" button, then fill in the application form with the required details and submit it.

What are the career prospects after pursuing a PG Diploma in Clinical Research online course?

Students can work as Clinical Research Associate, Clinical Data Manager, Biostatistician, Clinical SAS Programmer, Pharmacovigilance Specialist, and in pharmaceutical and healthcare companies.

Do students gain hands-on experience for the PG Diploma in Clinical Research certification course?

Yes, the students gain hands-on experience through various avenues like Electronic Data Base Capture (EDC) in clinical data management, safety database in pharmacovigilance, case processing, narrative writing, and Statistical Analysis Software (SAS).

What are the eligibility criteria to join the PG Diploma in Clinical Research online course?

Candidates can have graduate degrees in Science (Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology), Medicine (M.B.B.S, B.D.S, B.P.T, B.A.M.S, B.H.M.S, B.U.M.S), Pharmacy or Pharmaceutical Sciences (B.Pharm, Pharm.D).

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