Advanced Diploma in Clinical Research- ADCR

Learn from Industries Best Trainers


Contact our Course Advisor
Online Advanced diploma in Clinical-ADCR
Diploma in Clinical Research online Course1 -Bangalore Clinical Research Institute
Committed To Training Excellence

Our training centre offers an affordable Diploma program in Clinical Research, equipping students with the latest knowledge and effective teaching methods to prepare them for successful careers. Join us today to reach your fullest potential.

BCRI provides you an innovative learning approach which allows you as a student to apply the theoretical knowledge and skills gained during the taught Clinical Research Courses in an effective manner in the clinical research industry.

Kick start your career in a CRO

Advance your career with BCRI’s job-oriented Clinical Research Course. Get personalized guidance and hands-on experience from industry experts to succeed in the exciting field of clinical research. Enroll now to unlock your potential!

What we Teach ?

Our Advanced Diploma in Clinical Research Course helps healthcare professionals achieve their full potential in just four months. You’ll learn about important topics like Clinical Research, Clinical Data Management, Pharmacovigilance and intermediate regulatory affairs to help you succeed in your career advancement.

Our tutors are experienced professionals and will give you practical knowledge that you can use to make a difference in your career. You’ll earn an Advanced Diploma in Clinical Course and gain important tools for professional growth.

CDM Clinical Data Management -Bangalore Clinical Research Institute

Why Advanced Diploma in Clinical Research Course ?

The Advanced Diploma in Clinical Research is a program designed in such a way by the Bangalore Clinical Research Institute (BCRI) that it helps aspiring candidates learn about all important aspects of clinical research. The Advanced Diploma in Clinical Research course curriculum equips candidates with the right skills required to pursue careers in the clinical world.

This programme is built to produce high-quality clinical research professionals with the correct skill set needed to work in CROs. The Advanced Diploma in Clinical Research course opens a wide array of career options for candidates.

Skills you gain with (ADCR) - Clinical Research Diploma

Join a Comprehensive Clinical Research Training at BCRI, with Excellent Placement Track Record.
Who can Join ADCR?

The Advanced Diploma in Clinical Research is a four-month course. Anyone with a minimum 55% score in graduation in any of the life sciences or medical sciences can join this course, like MBBS, BDS, etc.) or a degree in science, pharmacology, pharmacy, life sciences, biotechnology, biochemistry, etc., pursued from a recognised university.

Admission to the Advanced Diploma in Clinical Research course depends on a candidate’s overall merit or performance in the relevant entrance examination conducted by the Bangalore Clinical Research Institute (BCRI).

Learning Objective
  • Phases of clinical trials
  • How many phases of clinical studies are there
  • A phase 0 study and Phase 5 clinical trial
  • Difference between clinical trial and clinical research
  • Clinical Research vs. Medical Care
  • What Is a Clinical Study?
  • Clinical Trials
  • Observational Studies
  • Conduction of Clinical Studies
  • Site for Clinical Studies and duration and Reasons for Conducting Clinical Studies
  • Participating in Clinical Studies and Who Can Participate in a Clinical Study?
  • Participants Protection and Considerations for Participation
  • Relationship to Usual Health Care
  • Active control studies
  • Phases of FDA approval
  • Percentage of drugs fail clinical trials
  • Microdosing
  • Dose Ranging
  • Single ascending dose (Phase Ia)
  • Multiple ascending dose (Phase Ib)
  • Trial design
  • Efficacy vs Effectiveness
  • Investigational new drug and New drug application

Process flow

  • Data management plan
  • Study set up
  • Tracking CRF Data
  • Entering data
  • Managing lab data
  • Identifying and Managing discrepancies
  • Collecting adverse Event Data


CDM systems

  • Where systems come from?
  • Choosing vendor products
  • Implementing New Systems
  • System Validation
  • Test plans
  • Migrating legacy Data
  • Change control


Study Set-up

  • Approved Protocol
  • Project Plan
  • eCRF Specification
  • Visit Form Matrix
  • DB design
  • DVS
  • UAT
  • IxRS Integration
  • Final Sign off – Go Live
  • DMP


Creating standards

  • Creating hierarchies
  • Sops and guidelines
  • Working with CROS
  • CRF Design Consideration
  • Remote Data Entry
  • Data entry in RDC and Discrepancy Management in RDC
  • Auto coder Algorithms


Clinical Trial Management

  • Fundamentals of clinical trials
  • Basic statistics for clinical trials
  • Clinical trials in practice
  • Reporting and reviewing clinical trials
  • Protocol development
  • Trial designs
  • Project management and research co-ordination
  • Regulatory affairs, good clinical practice and ethics
  • Data management
  • Data monitoring and interim analyses
  • Data reconciliation
  • DCMs and DCIs


Study Conduct

  • Tracking CRF
  • Data Creating, Data Collection Modules and layouts
  • corresponding to CRFs to allow for data entry
  • Entering data, Generating and Testing data entry screens and validate the range,
  • format, date, missing fields
  • Data validation
  • User acceptance testing (UAT)
  • Managing lab data
  • Identifying and Managing discrepancies
  • Collecting AE Data
  • SAE Reconciliation
  • Reviewing clinical data as per SOP, protocol, and study specific guidelines
  • Medical Coding
  • IxRS Reconciliation
  • Listing Reviews, consistency checks
  • QC
  • Status Reports
  • All Subjects completed final visits/f-up visits
  • Medical Coding data review completed and issues resolved
  • Final SAE reconciliation
  • All queries resolved and DB updated
  • Final review completed
  • All expected forms and visits are locked/frozen
  • QC steps conducted and QC plan and report documented
  • QA issues addressed if any
  • All documentation completed as per DMP and stored according to SOP
  • Data is archived/submitted

Introduction of Drug Discovery and Development

  • Discovery and Development
  • Preclinical Research
  • Clinical Research
  • Drug Review
  • Post Market Drug Safety Monitoring

Introduction to Pharmacovigilance

  • Pharmacovigilance (WHO Definition)
  • History of Pharmacovigilance
  • Scope and purposes of Pharmacovigilance
  • Basic Concepts: Terms and definitions
  • General idea of PV and types of AE reporting
  • Types and sources of data
  • The process of Pharmacovigilance- Signal Detection and Drug recall
  • What are safety signals?

 Pharmacovigilance Reporting Database

  •  Risk Assessments & Evaluation
  • Reporting Criteria to Health authorities and timelines
  • Quality System In PV
  • Expedited Reporting Criteria
  • Different reporting formats used in PV
  • PSUR and DSUR overview
  • PV Database and Signal Detection
  • Safety ignals
  • Signal Management
  • Risk Assessments & Managements

PV Database Index

  • Case receipt
  • Data verification and validity check
  • Triage
  • Duplicate search
  • Book in and registration
  • Data Entry
  • Coding of AE and Drugs

 Causality assessment

  • Expectedness assessment
  • Why causality assessment
  • WHO –UMC causality assessment system
  • Case Narrative
  • Quality check
  • Reporting or Submission
  • Deletion and nullification
  • Initial Receipt date and Day 0 Importance
  • Case linking, Mother and Baby cases
  • Special Case Scenarios: LOE, Off-Label use, Misuse, Overdose, Pregnancy &
  • Medication Error
  • Practicing Real Time cases scenarios

Drug Dictionaries, ADR dictionaries and Coding of the events

  • WHO drug dictionary
  • MedDRA
  • ADR classification
  • SAE and Seriousness criteria

 Narrative Writing

  •  Overview and Characteristics Case Narrative
  • Sections of Case Narrative
  • Steps and Construction of a narrative
  • Introduction to Global Regulatory Authorities for pharma and healthcare industries
  • Regulatory affairs in clinical research
  • WHO –UMC (Uppsala Monitoring Committee), CIOMS
  • Drug Development Process, Clinical Trials and related norms and regulations
  • European Pharmacovigilance System
  • FDA Good Clinical Practice (GCP)
  • ICH Good Clinical Practice (ICH-GCP) guidelines clinical trials
  • International Council for Harmonisation
  • GCP in pharma, Main GCP principles, GCP compliance
  • GMP and other good practices.
  • Institutional review board(IRB) / independent ethics committee (IEC)
  • Quality Assurance and Drug Regulations, ICH and WHO guidelines
  • Technical Requirements for Pharmaceuticals for Human Use
  • Data monitoring committees
  • European Forum for Good Clinical Practice(EFGCP),European Medicines Agency (EMEA)
  • Dossier preparation in CTD format, eCTD submissions
  • Healthcare Industry IPR, Patents, copyrights and Trademarks
  • Pharma and Healthcare products- Marketing, Import and Export regulations
  • Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and Breach reports
  • Indian GMP Regulations
Scheduled Batches

The Advanced Diploma in Clinical Research (ADCR) program equips students with a diverse set of skills essential for a successful career in the clinical research field. You’ll develop a solid understanding of the principles, regulations, and processes involved in clinical research. This includes practical knowledge, EDC software, Case processing, Narrative writing, etc..

The coverage of pharmacovigilance and drug safety monitoring in an Advanced Diploma program typically involves a comprehensive exploration of the intricacies of monitoring and ensuring the safety of pharmaceutical products throughout their lifecycle. The Advanced Diploma program covers Pharmacovigilance Overview, Drug Safety Monitoring, Regulatory Aspects, Expedited and Periodic Safety Reporting, and Hands-On Experience.

The role of practical training or internship in an Advanced Diploma in Clinical Research is crucial for several reasons, and it significantly enhances the overall learning experience of participants. Practical training and internships are integral components of the Advanced Diploma in Clinical Research. Practical training allows participants to apply theoretical knowledge in real-world scenarios. It bridges the gap between classroom learning and the actual practices within the clinical research industry. Participants have the opportunity to develop and hone practical skills essential for roles in clinical research, such as data collection, monitoring, regulatory compliance, and project management with EDC software like Clinevo.

BCRI’s Advanced Diploma program prepares students for roles in clinical research by providing specialized coursework and practical training, emphasizing in-depth knowledge of trial design, data management, and regulatory affairs. The program aims to equip students with a comprehensive skill set for leadership positions in the industry.

The Advanced Diploma in Clinical Research program covers essential topics to equip healthcare professionals for successful careers in the clinical research field. The key modules you’ll explore during this course are Clinical Research, Clinical Data Management, Pharmacovigilance, Regulatory Affairs, and developing skills in writing clinical trial protocols, reports, and other scientific documents. This comprehensive program aims to prepare you for a rewarding career in the clinical research industry. If you have a background in life sciences or medical sciences, you’re eligible to join this four-month course and unlock your potential!

The ADCR course duration is four months. The course is conducted live instructor mode. Everyday sessions would be for 1 to 1.5-hour, followed by hands-on assignments and class recordings.

Anyone who is Life science, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT) are eligible for Advanced Diploma in Clinical Research Course.

Absolutely! Our training materials and courses are designed for easy access, our courses are structured into independent modules like a) Pharmacovigilance b)Regulatory affairs c)Clinical Research d)Clinical Data Management with distinct learning procedures and practical applications on real-time scenarios.

We are delighted to let you know that we offer a wide array of comprehensive online clinical research courses that cater to the needs of international students in various countries including the United States of America (USA), Canada, and Australia. Our courses are designed to meet the highest standards of quality education in the field of clinical research.

Moreover, these courses are conveniently available online, enabling students from around the world to have access to them at any time and from the comfort of their homes. Through our online platform, we provide our students with a flexible learning experience, allowing them to tailor their studies to their specific needs and preferences.

Our experienced and dedicated teaching staff is committed to providing our students with the knowledge and skills they need to excel in their careers in clinical research. Enroll in our courses today and gain an edge in your career.

The Trainers at BCRI India are well organized and experienced in their fields like clinical Trial Management, Clinical Data Management, or Regulatory Affairs. The trainers will take responsibility for evaluating the needs and current practices and creating a development plan with materials and learning resources.

Our Trainers are confident public speaker and subject Matter specialist to educate. Our Trainers are up-to-date on the latest tools and Industry resources needed to improve employee training and performance.

The BCRI Clinical Research trainer will also be responsible for researching and selecting the best platform to deliver and utilize training materials.
Bangalore Clinical Research trainers can design and implement various learning and developmental programs for clinical research for comfortable working in the industry with groups of all sizes.
Our trainers are experienced, dynamic, well versed in strong clinical industry knowledge with excellent communication, management, and developmental skills.

BCRI trainers have not only the ability to convey information concisely and accurately but also the ability to make the students highly potential and competitive by providing real-time exercises.

Yes, We do have 100% placement Support on the successful completion of the course. Each student is entitled to placement assistance. Our placement officer is dedicated to finding a suitable opportunity for each student.

We are proud to state within a short duration, we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in Pharmacovigilance departments, QA personnel in medical writing departments, and as Jr. SAS programmers.

Students who have completed a course in clinical research from any other organization may approach us for internship assistance.
We cannot guarantee that a company will hire you, as it is based on your performance during an interview. However, we do provide 100% placement assistance. To date, we have a 100% Placement record.

Online Advanced Diploma in Clinical research course is conducted using an online training platform like Zoom.us, goto training, google meet, etc. Online clinical research is a good way of learning from any part of the world.

As compared to conventional classes opting for online ADCR classes are a better choice to learn clinical Research, Clinical Data Management, Pharmacovigilance, and Regulatory Affairs. During online classes, you get everyday class recordings for lifetime access along with e-notes and assignments.

BCRI distinguishes itself in clinical research training through a comprehensive curriculum, hands-on projects, and potential industry collaborations, fostering advanced skills for successful careers. For specific details, consult BCRI’s promotional materials or contact the institution directly.

To enroll in our Advanced Diploma in Clinical Research (ADCR) program, please visit our official BCRI website, where you’ll find the admissions section. Follow the provided application process and submit the necessary documents. If you have any questions or need guidance, feel free to contact our admissions department. We look forward to welcoming you to BCRI.

Reviews From Our Happy Students

Creating Vibrant Career & Secured Future!
Teena Rajan
Read More
I have completed Advance PG diploma in Clinical Research and Pharmacovigilance from BCRI. My PV trainer was Dev sir. My CDM trainer was Ishani mam. Dev Sir,is very interacting and he made our class interesting. He is very much knowledged and clears all our doubts. He is good in explaining all concepts. I had an amazing experience . I truly recommend this course from BCRI to all PV aspirants.
Meghna Mahesh
Read More
I have done Post graduation diploma in Clinical research and Pharmacovigilance. Classes were very informative and Mayuri ma'am and Samarth sir are very knowledgeable and they have explained each and every word of the clinical research and that made the classes very informative and interesting. Very good institute.
Nikita Jaiswal
Read More
I have done my PG diploma in clinical research from BCRI. This complete program of pg diploma was very helpful for me to upskill my self in clinical research domain after my graduation. This course include complete knowledge of clinical research, clinical data management, pharmacovigilance and SAS. Read More
Manasi Phadnis
Read More
When I enrolled myself in PG diploma at BCRI, I got to know that we are going to be mentored by Mayuri ma'am for PV. I was really excited and eager to be studying under Mayuri ma'am as I had already read a lot about her in the Google reviews. Read More
Naga Nikhila
Read More
My training in BCRI has been great. I have completed my pg diploma in clinical research, clinical data management, pharmacovigilance and RA with excellent support and guidance from the faculty.

Visit Us On

Help to make a difference in people’s lives.

"Join Clinical Research Industry"

The best online courses you'll find.

Join A Course
Request for a free Demo !

Our Team would love to Guide you to select the right course here .

Contact Course Advisor

Online clinical research Course completion award