Program Project Report – PPR

(Approval of the Board of Studies and Academic Council)

Name of the School: Symbiosis School For Open and Distance Learning [SSODL]

Name of the Program: Post Graduate Diploma in Pharmacovigilance & Clinical Data Management

S.No. Parameters Details

a. Programmes mission & objectives::

(its alignment with industrial/ learner demands)

Program Mission To train/prepare graduates for industry oriented knowledge, which will help them to be

professional in the Pharmacovigilance and Clinical Data management.

Objectives:

1. Provide an overview of clinical research and other major concepts of

pharmacovigilance & clinical data management.

2. Gain in-depth knowledge on Med DRA, Pharmacovigilance program of India

(PvPI), risk & data management activities.

b. Relevance of program with SIU’s Mission & Goals: As per the SIU mission i.e.

To enhance employability and contribute to human resource development

To contribute towards knowledge generation and dissemination

To promote ethical and value-based learning

To deliver essential theoretical and industry inputs to enhance creative thinking

among Future experts and professionals in the field.

c. Nature of prospective target group of learners :

1. Specify the target group:

2. Needs of the target group:

(Annex Report of Exploratory Expert Committee

Any graduate with an aptitude to acquire, knowledge and skills in the following areas:

Clinical Data Coordinator

Drug Safety Associate

Pharmacovigilance Specialist/Scientist

CDM Data Analyst

Vigilance Managers

S.No. Parameters Details

Meeting and Need Assessment Study) Clinical Data Manager

There is a felt need in the Pharmaceutical industry, Biotech companies, Clinical Research

Organization, Regulatory agencies, etc. for trained professionals in the above-mentioned

areas.

d. Appropriateness of program to be conducted in Open &

Distance Learning (ODL) mode to acquire specific skills

& competence :

Specify the expected learning outcomes in terms of:

1. Knowledge attainment:

2. Transferable Skills and Competencies:

3. Reflection of academic, professional and

occupational standards:

Post graduate diploma in Pharmacovigilance & Clinical data management aims to develop

professionals aspiring to work in the fields of Pharmaceuticals, Clinical research

organizations by imparting quality training and knowledge on various aspects of adverse

drug reaction, causal relationship, effectiveness, efficacy, risk factors in different phases

of clinical research. It gives opportunity to upgrade their knowledge and skills required for

the systematic assessment, monitoring, examining of clinical conditions, prevention of

adverse effects with pharmaceutical products and generating evidence for clinical decision

making for improving patient outcomes.

It covers history and evolution of Clinical Research, Pharmacovigilance Program of India

(PvPI), Pharmacovigilance workflow and quality management, Types of reports, Clinical

data management soft wares, SAE Reconciliation, Data management activities, Signal

detection methods. The program covers a broad spectrum of Drug development process,

National and Global Regulations, Aggregate reporting, Risk management plan, etc.

Demands of skills and competencies are varying at faster pace, due to competitive and

rapid market changes predominately in Small and Medium Enterprises, which urges for

provision of flexible, work-integrated, continuous training, learning and development

opportunities through Higher Education Institutions. The traditional and formal

educational delivery may not achieve this at rapidly changing demand with flexible

approach.

To fulfill these needs, Symbiosis as a HEI for distance learning, plays important role by

S.No. Parameters Details

providing flexible and cost effective education to enhance their productivity skills while

continuing regular employment. Open and Distance mode is suitable to reach out to the

target group particularly the working healthcare professionals, offering them an

opportunity to upgrade their knowledge and skills required in the clinical research

industry.

The renowned industry experts, has designed self-learning material for this program,

considering recent advancement in the field. Program is reviewed and revised periodically

to keep the content upgraded to make it contemporary. Practical training will enable

learner hands on training in the field

The assessment of each learning outcome is done annually to identify that the established

learning objectives are achieved. The gaps identified after the analysis are addressed

through the properly laid action plan. Each course has its specific Objective around which

the entire curriculum is designed. Carrying out project gives hands on training to the

learner.

In order to ensure that the objectives and outcomes are in complete synchronization with

the course outline, the department uses a list of assessment methods to analyze the output

by examining the learners from different aspects. The results of the annual assessments

and other data are used to determine the effectiveness of the program during the Program

review process.

Program Learning Outcome:

Pharmacovigilance & Clinical Data Management program is geared to enable

learners to:

Be familiar with Tools, techniques, and methodologies used in drug safety

S.No. Parameters Details

evaluation

Identify Safety-related issues and queries in early and late drug development

Keep upbreast with changes in safety assessment as a part of a new drug

development paradigm

Know types and list of CDM tools available for research

Understand different CRF tracking processes

e. Instructional Design :

Course Curriculum: Institution adopts a specialized approach where the course development task is assigned to professionals in the particular

department of the university and/or external experts. A draft is evaluated by Institutional PRC which includes a team of experts to review the proposed

course curriculum that meets the objectives of distance education.

Program Structure: Institution constitutes a team of experts – Specialization sub-committee to review the course structure. This committee provides its

feedback and recommendations to the concerned faculty following which the program structure is revised.

Study Materials: The study material is Self-Learning Material (SLM) format, which is the essence of standard distance learning Programs. Thus,

Institution initiates to develop all materials in SLM format. Both internal & external experts, write the study material according to specific guidelines laid

down by the statutory body HEI.

Review by Board of Studies: The course is diligently reviewed by BOS. Recommendations of BOS are incorporated in program structure. It also checks

& defines the applicability, credit hours, scheme of examination for the course.

Approval by Academic Council: The course is submitted to the Academic Council of the University for Final Approval. Programs are offered on annual

S.No. Parameters Details

basis. A modular approach towards pursuing abiding diploma program is implemented. The breakup of one credit worth of student’s effort, i.e. 30 hrs,

typically have the following components. Academic activities are linked together to engage the learner and maximize learning.

Curriculum

design

Total

Credit

hours

Detailed syllabi Duration of

the program

Medium of

instruction

Type of

program

Faculty and

Support staff

Student

Support

Service system

Introduction

to Clinical

Research

4 1. What is Clinical Research?

2. Clinical Research Terms

3. Evolution of Clinical Research

4. Ethics of Clinical Research

5. Drug Development Process

6. Phases in Clinical studies

7. Clinical Research in India

8. Careers in Clinical Research

9. Roles and Responsibilities of Clinical

Trial Professionals

1 English PG diploma Professor (1)

Asso.

Professor (1)

Admin and

support staff

(2)

Academic

counsellor

(1)

SLM

Online Chat

Video lectr.

PPT

E learning CD

E counselling

Global

Pharmacovig

ilance

08 1. Overview of Pharmacovigilance

2. Collaboration with World Health

Organization

3. International Conference on

Harmonization (ICH) Guidelines

4. Pharmacovigilance in Different

countries

S.No. Parameters Details

5. Pharmacovigilance Programme of

India (PvPI)

6. Pharmacovigilance workflow

7. Quality management

8. Adverse Events and Serious Adverse

Events

9. Types of Reports

10. Medical Aspects of Pharmacovigilance

11. Indian Regulations and Global

Regulations

12. Pharmacovigilance (PV) Audits

13. Pharmacovigilance Inspection

Risk

management

4 1. Aggregate Reporting

2. Signal Detection and Data Mining

3. Signal Detection Methods

4. Introduction and important definitions

5. Risk Management plan

6. Structure of Risk

7. ICH E2E Guidelines

8. European Medicines Agency (EMA)

and QPPV

9. Good Manufacturing Practices (GMP)

Standard

guidelines in

4 1. Definition, Importance, Process flow,

Roles

S.No. Parameters Details

data

management

2. Data Management Start up Activities

3. Data Management conduct Activities

4. Data Management Close out Activities

5. Standards, Guidelines, Metrics and Data

Quality

6. Standard Guidelines- ICH-GCP

7. Standard Guidelines- 21 CFR Part 11

8. Standard Guidelines- Society for

Clinical Data Management (SCDM)

9. Standard Guidelines- CDISC, CDASH

and DSMB

Data

management

activities &

Software

08 1. Overview of Project Planning

2. Data collection

3. Data Entry

4. CRF Tracking

5. Clinical Data Management Systems

6. Study Database

7. Clinical Trial Management Systems

(CTMS)

8. Load and Review of External Data

9. SAE Reconciliation

10. Introduction to CDM Tools

11. Oracle Clinical (OC)

12. Open Clinica

13. Data Coding

S.No. Parameters Details

14. Data Queries

15. Data Base lock activities

Project 4 Survey base project

Total 32

f. Procedure for admissions, curriculum transaction and

evaluation:

1. Define the admission policy (including web based

tools to be adopted) :

2. Eligibility criteria:

3. Fee structure:

4. Financial assistance to learners (if any):

5. Activity planner of all academic activities of the

academic session:

6. Policy for Evaluation of learner progress along with

methods and tools:

Step 1: Register online

Step 2: Pay online registration fees

Step 3: Fill up the online application form

Step 4: Print the application form and attach the requisite scan documents and photo.

Step 5: Courier it to SSODL

Step 6: Document verification for eligibility of the applicant

Step 7: Pay online program fees after the eligibility checked

Step 8: Receive study material after 15 working days of confirmation of admission date

Verification of eligibility of the applicant is done and then only admission gets confirmed.

Refund/ Cancellation:

Registration Fees: Non refundable

Program/ Admission Fees :

In case, the student wants to cancel his admission from SSODL then he has to raise the

admission cancel request from his /her student login within 15 days from the date of

admission.

On the acceptance of admission cancellation, request 100% program fees will be

refundable to the student.

S.No. Parameters Details

Eligibility criteria:

Candidate should be a graduate in any discipline from any statutory university

Fee structure:

Indian student

Program Fees: 42,000/-

Foreign Student

Program Fees: $ 1050 (USD equivalent to INR)

Financial assistance to learners (if any): NA

Activity planner: Entire timelines from admission to certification (uploaded on website)

Activity Planner

Batch Admission

Period

Session

Duration

Academic

Activities

Date of

Submissions

Batch I Jan 2020

to

Sep 2020

July

2020 to Ju

ne 2021

(One

Year)

Assignment

Submission

1st Set

2nd Set

Case Study I

Case Study II

1st December,

2020

1st February, 2021

1st January, 2021

15th March, 2021

S.No. Parameters Details

Contact

Session

Term End

Examination

April/May, 2021

May/June, 2021

Batch I

I

Oct 2020

to

Feb 2021

Jan

2021 to D

ec 2021

(One

Year)

Assignment

Submission

1st Set

2nd Set

Case Study I

Case Study II

Contact

Session

Term End

Examination

1st May, 2021

1st July, 2021

1st June, 2021

15th September,

2021

April/May 2021

December, 2021

Policy for Evaluation of learner progress along with methods and tools:

S.No. Parameters Details

Formative assessment (Weightage 30%):

Assignments

Project work

Summative Assessment (Weightage 70%)

Term End Examination

g. Requirement of the laboratory support and library resources:

1. Laboratory support to the learners (if any):

2. Provision of Practical book for learners (if any):

3. Provision of Virtual Reality methods for Practicals

in case of Online learning (if any):

1. Laboratory support: NA

2. Provision of Practical book for learners (if any): NA

3. Provision of Virtual Reality methods for Practical’s in case of Online

learning (if any):

Students can read reference books from FoHBS library.

Provision of Reference book: The Institution provides the provision of reference

book to students who want to get extra knowledge on a particular subject.

Guidance by Course coordinator through telephone email & chat rooms

Personal Contact Program (PCP): The Institution conducts Personal Contact

Program (PCP) at the end of the year to help students interact with the faculty and

get their queries and doubts resolved

Assignments, Project Work: Besides the SLM, students are provided with

assignments and project work. Learners are assisted by faculties to complete these

criteria to attain comprehensive knowledge & skills to be industry ready.

S.No. Parameters Details

Recording of seminar / Conference / Workshop available Online

h. Quality assurance mechanism and expected program

outcomes*:

1. Define the review mechanism of the Programme for

enhancing the standards of curriculum, instructional

design relevant to professional requirements:

2. Define Programme benchmark statements:

3. Mechanism for monitoring the effectiveness of the

programme:

*Minimum standards must adhere to UGC (ODL)

Regulations, 2017 and directions of the Statutory Bodies

of the University

Centre for Internal Quality Assurance will monitor, improve and enhance effectiveness of

the program through the following:

Annual academic audit

Feedback analysis for quality improvement

Regular faculty development programs

Standardization of learning resources

Periodic revision of program depending upon the changing industry trends

Well defined policy for course design and development and learner support available on

website