ONLINE COURSES

Advanced Postgraduate Diploma in Clinical Research &
Data Management
Online Training in Clinical Research & Data Management | Clinical Data Management Course

Online Training in Clinical Research & Clinical Data Management | Clinical Data Management Course

The training course Advanced Post Graduate Diploma in Clinical Research & Data Management (APGDCR-DM) is designed to provide students with a complete overview of clinical research, clinical data management and a hands on experience of the management of clinical trial data via an instructor led online training of the data management software - Oracle Clinical (OC).

The course has been developed with extensive consultation with the clinical data management industry and is structured in a way so as to open up opportunities for students in the area of core clinical research as well as clinical data management (CDM).

The program is highly recommended for all individuals already working or planning to work with clinical data and other related health databases.

The program APGDCR-DM has been designed to provide students a stimulating and enjoyable experience so as to develop them into skilled, efficient professionals who are highly employable and capable to work from day one in clinical research and clinical data management.

The Advanced Post Graduate Diploma in Clinical Research & Data Management (APGDCR-DM) course curriculum is fully reviewed and endorsed by the clinical research and clinical data management industry thus imparting students the edge that they require to make an entrance in the this industry and empowers the professionals to move to higher cadres in the clinical research and data management hierarchy.

Course Structure

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
MODULE 14 MEDICAL DEVICE TRIALS
MODULE 15 PROJECT AND VENDOR MANAGEMENT
MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

CLINICAL DATA MANAGEMENT

MODULE 18 BASICS OF CLINICAL DATA MANAGEMENT
MODULE 19 CLINICAL DATA MANAGEMENT PROCESSES & STANDARDS
MODULE 20 CLINICAL DATA MANAGEMENT SYSTEMS
MODULE 21 ORACLE CLINICAL

ORACLE CLINICAL - INSTRUCTOR LED LIVE ONLINE SESSIONS*

SESSION 1 Planning a Study
SESSION 2 Designing a Study
SESSION 3 Creating and Testing Data Entry Screens - Part 1
SESSION 4 Creating and Testing Data Entry Screens - Part 2
SESSION 5 Designing Generating, Executing and Testing Validation Procedures-1
SESSION 6 Designing Generating, Executing and Testing Validation Procedures-2
SESSION 7 Performing Production Data entry - Part 1
SESSION 8 Performing Production Data entry - Part 2
SESSION 9 Discrepancy Management
SESSION 10 Generation, Printing and Resolution of Data Clarification Forms (DCFs)

* - During the online live sessions students are provided full access to the Oracle Clinical Application.

- Live sessions are scheduled during the program as per the convenience of students and instructor.

Course duration

Self Paced 6 - 8 months (Maximum duration 24 months)

A student enrolled for the Advanced Postgraduate Diploma in Clinical Research & Data Management course is expected to study online for a minimum of fifteen hours per week.

Course Assessment

Course assessment involves online MCQs for each lecture, followed by assignments and numerous assessments by tutors in the "Online Campus Tutoring Centre" by the method of interactive discussion.

Eligibility Criteria

Minimum eligibility criteria for the course would be either of the following:

MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.

Fee Structure

Course fee for all JLI courses is very reasonable. Please use our Course Fee Calculator below to know the course fee applicable to you.

If you are not sure about the fee applicable to you for Advanced Postgraduate Diploma in Clinical Research & Data Management for the academic year 2012-13 please send an email to admissions@jli.edu.in or chat with our online counsellor.

For more details about the admission procedure please click here.

Academic Support

Each student enrolled for the Advanced Postgraduate Diploma in Clinical Research & Data Management course is assigned a mentor throughout the course who will be a senior professional from the Industry. Students are in close contact with the "Student Success Team" during the course and thereafter as alumni. To know more about the "Student Success Team", click here.

A study report published by Frost & Sullivan, "World Pharmacovigilance Markets in Life Sciences," states that the pharmacovigilance market was worth US$1859.9 million in the year 2008 and is estimated to be US$2252.2 million by 2015.

JLI students get the opportunity of reading, listening to lectures, additional reference readings, exercises and assignments, as many times as they may need during the course to attain maximum understanding of the subject. This is substantiated by a prompt query resolution support by well learned faculty from the industry. This kind of personalized approach takes away the constraints of distractions, missed classes, fatigue and sometimes-unbearable ennui seen in regular classrooms.

Training Feedback:

Thanks for taking us all through the entire OPA sessions. It was a wonderful learning experience for me to learn Oracle Clinical through an online class. I appreciate your patience and understanding in clearing everyone's doubt throughout the entire sessions. All the sessions were well organized from your side. I also thank you for taking all the sessions in a simplified manner to everyone's level of understanding.
Bala Murali
Asst. Team Lead - Point Perfect Transcription Services

Your classes were wonderful. You are so thorough with the concepts and have an in-depth knowledge of the application. That makes you an excellent mentor. You were very considerate about our issues and took action immediately to help us, specially by enabling us to access the Oracle pharmaceutical apps link at almost all times.
Veena Chandra
Healthcare Professional

Advanced Postgraduate Diploma in Clinical Research & Data ManagementOnline Training in Clinical Research & Data Management | Clinical Data Management Course

Advanced Postgraduate Diploma in Clinical Research &
Data Management
Online Training in Clinical Research & Data Management | Clinical Data Management Course