Vide Item No 66 N Certificate Course in Clinical Date Management_1 Syllabus Mumbai University by munotes
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1. The Deputy Registrar, Academic Authorities Meetings and Services
(AAMS),
2. The Deputy Registrar, College Affiliations & Development
Department (CAD),
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9. The Director, Institute of Distance and Open Learni ng (IDOL Admin),
Vidyanagari,
They are requested to treat this as action taken report on the concerned
resolution adopted by the Academic Council referred to in the above circular
and that on separate Action Taken Report will be sent in this connection.
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for information.
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AC - 17/05/2022
Item No. 6.6 (N)
UNIVERSITY OF MUMBAI
Syllabus
For
Certificate Course in
Clinical Data Management
(To introduce with effect from the academic year 2022 -23)
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PREAMBLE
This is with reference to the AICTE Initiative & University of Mumbai guidelines, Clinical
Data Management (CDM) , thirty hours Value added certificate course is introduced from the
academic Year 202 2-23. The students may take up this course as value -added certificate course
offered by their institute while pursuing their education in pharmacy.
The Primary aim and scope of this 30 hours certificate course is to impart specific skills that
students must acquire during their academic program with the aim of preparing well -rounded
learners and to make the candidates employable as entry level resources in the domains of Clinical
Data management, Pharmacovigilance/drug safety in BPOs, Pharmaceutical companies, Contract
Research Organizations (CROs). The Program will serve as a sound introduction to the CDM
domain for Pharmacy students even if th ey plan on not joining the domain in their industry career.
The syllabus for the course shall be subjected to revision after every three years.
O.6795 :
Title of Course
"Certificate Course in Clinical Data Management”
O.6796 :
Eligibility
A candidate for being eligible at admission to the Certificate Course in
‘Clinical Data Management’ must be student pursuing UG/ PG / Ph.D.
program in Pharmacy; preferably completed two years of a graduation
program in Pharmacy.
R.9556 :
Duration of Course
30 Hours
R.9557 :
Intake Capacity:
Maximum 45 candidates in one batch
Teachers: Subject experts from HEIs and industry having the domain knowledge.
Regulation: Fees
It is an autonomous value -added paid course conducted at the
Institution level. Examination will be conducted by the Institute and
certificate will be issued by the Institute. However, the certificate will
be jointly signed by the principal and Director, BOEE with logos of
both organisation appearing on the certificate. All financial aspects
will be t aken care by the institution running the course. There won’t
be any provision for sharing of fees with University of Mumbai.
EXAMINATION/ ASSESSMENT AND GRADING:
The certificate course shall be conducted at the Institute level. The institute shall conduct an
examination and issue a certificate of completion of the course with credits assigned.
Performance assessment of every registered learner is to be carried out through various modes of
examinations. These include Internal Assessment and Course Completion Exam.
Table -1: Scheme for Assessment
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Nature of Assessment Nomenclature Maximum
Marks
Internal Assessment/ Continuous
Mode of Assessment: to be
conducted intermittently during the
course conduction Quiz 1 10
Quiz 2 10
Quiz 3 10
Quiz 4 10
Course Completion Exam: to be
conducted upon completion of the
course Course Completion Exam 60
Total 100
Paper pattern for Internal Assessment i.e. Quiz
Question paper pattern for Quiz:
I. Multiple Choice Questions (MCQs) [Duration: 20 Mins] = 10 x 1 = 10
(Answer all the questions)
Total = 10 marks
Paper pattern for Course Completion Exam
Question paper pattern for Course Completion Exam:
MCQs : (Answer all the questions) [Duration: 60 Mins] = 30 x 2 = 60
Total = 60 marks
GRADING OF PERFORMANCES
Letter grades and grade points allocations:
Based on the performances, each student shall be awarded a final letter grade at the completion of
the course .The letter grades and their corresponding grade points are given in Table – 2.
Table – 2: Letter grades and grade points equivalent to Percentage of marks and performances
Percentage of Marks Obtained Letter Grade Performance
90.00 – 100 O Outstanding
80.00 – 89.99 A Excellent
70.00 – 79.99 B Good
60.00 – 69.99 C Fair
50.00 – 59.99 D Average
Less than 50 F Fail
Absent AB Fail
A learner who remains absent for Course Completion E xamination shall be assigned a letter grade
of AB and a corresponding grade point of zero. He/she should reappear for the said
evaluation/examination in due course.
CRITERIA FOR AWARD OF THE CERTIFICATE:
A student shall be declared PASS and eligible for getting the certificate of completion of the
course if he/she secures at least 50% marks in the course out of total 100 marks. There is no
separate criteria for passing in individual head of assessment.
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The list of the students successfu lly completing the certificate course will be submitted by the host
institute to University of Mumbai along with the certificate signed by the head of the host
institute. The certificate will be jointly signed by the head of the host institute and Director , Board
of examination and evaluation and will bear logo of both - host institute and University of
Mumbai.
The detailed syllabus of the Clinical Data Management (CDM) certificate course is given in the
consequent section of this document.
Dr. Anuradh a Majumdar (Dean, Science and Technology)
Prof. Shivram Garje (Associate Dean, Science)
Prof. Supriya Shidhaye (Chairperson BoS)
Dr. Shrirang Joshi (Member BoS)
Prof. K.G. Akamanchi (Member BoS)
Prof. Krishna Iyer (Member BoS)
Prof. Rajani Athawale (Member BoS)
Dr. Mohan Kale (Member BoS)
Dr. Meena Kanyalkar (Member BoS)
Clinical Data Management (CDM)
(Total Hours - 30)
Course Code Course Name Credits
PH-CDM Clinical Data Management (CDM) 03
Prerequisites: Basic understanding of diseases (Pathology), Pharmacology and Clinical Research.
Course Outcomes: After completion of this course students should be able to:
o Demonstrate in depth understanding concepts of CDM and its importance, relevance and
execution in the ambit of clinical development.
o Demonstrate knowledge about the use of suitable data management tools for the generation
of high-quality, reliable, and statistically sound data from clinical trials .
This will make them employable in the clinical research associated sponsor, CRO and BPO companies
for jobs associated with CDM.
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Unit no. Course content (topics and subtopics) Hours
1 Introduction to Clinical Data Management (CDM):
Principles of CDM
Data and databases
Electronic data capture
Data Entry
Transcribing data
Queries & Data Clarification
Software in CDM 4
2 Data management plan 2
3 Clinical Data Management System (Preferably demonstrated
using suitable Electronic Database Management System) 2
4 Clinical data repositories 2
5 Loading of external data into CDM system 1
6 Query management 1
7 Data clarification form 1
8 Remote data entry 1
9 Clinical data entry – single, double, SAE reconciliation , coding
of Adverse events 4
10 Data cleaning and data validation 1
11 Analysis Data model (ADaM) and STDM (Study Data
Tabulation Model) 2
12 Working with missing values, outliers, start and end dates 1
13 Data base lock (DLP) 1
14 System validation 1
15 eCRF designing & data tracking 2
16 Clinical data archiving 1
17 CDM Service Level Agreement (SLA) 1
18 Quality Assurance (QA) in CDM 2
Total 30
Reference books:
1. Practical Guide to Clinical Data Management, Third Edition by Susanne Prokscha
2. Data Management for Researchers: Organize, maintain and share your data for research success
(Research Skills) Paperback – September 1, 2015 by Kristin Briney
3. https://www.scdm.org/publications/gcdmp/ (several publications are available on SCDM website for
free or for nominal fee if you join as a member)
4. Research Data Management: Practical Strategies for Information Professionals (Charleston Insights
in Library, Information, and Archival Sciences) by Joyce M. Ray
5. Latest Regulatory Guidelines related to CDM a nd Clinical Data Reporting.
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(Appendix ‘B’)
New ordinances 6795 & 6796 relating to the
Certificate Course in Clinical Data Management
1 Necessity of starting these courses
The primary aim and scope of suggesting value -added course under
mentioned are to boost the employability of the B. Pharm students and to
help them to be at par with global trends and global technology.
‗Clinical data Management Course (CDM)‘ for Pharmacy students is to make
the candidates employable as entry -level resources in the domains of
Clinical Data management, Pharmacovigilance/drug safety in BPOs,
Pharmaceutical companies, Contract Research Organ izations (CROs). The
Program will serve as a sound introduction to the CDM domain for
Pharmacy students even if they plan on not joining the domain in their
industry career.
2 Whether UGC has recommended to start the said courses?
UGC Quality mandate states that to ensure holistic development of the
students at the university/college level, efforts need to be made to reorient
the teaching pattern with a focus on all types of courses including Elective
courses — chosen by students from other departments as per their aptitude.
UGC Quality mandate mentions Learning Outcome -based Curriculum
Framework (LOCF) — revision of curriculum in regular intervals. Under this
objective, UGC suggests that HEIs should boost the employability of
graduates through curricul um reform.
National Education Policy (chapter 20.5) mentions –―India must also take the
lead in preparing professionals in cutting -edge areas that are fast gaining
prominence, such as Artificial Intelligence (AI), 3 -D machining, big data
analysis, and machine learning, in addition to genomic studies,
biotechnology, nanotechnology, neuroscience, with important applications to
health, environment, and sustainable living that will be woven into
undergraduate education for enhancing the employability of the youth‖
3 Whether all the courses have commenced from the academic year 2022 -
23?
It is proposed to be introduced from academic year 2022 -23. Since it is
avalue -added course, not confined within the framework of syllabus of B.
Pharm/ M. Pharm / Ph.D. for award of degree or credit transfer, any
affiliated Pharmacy college can conduct the course based on the availability
of the resource persons and interest of the students. Students may take up
the course as per their interests. Any student pursuing UG/ PG / Ph.D.
program in Pharmacy is eligible for admission to this course. The course can
be taken anytime, preferablyupon completion of the second year B. Pharm
4 The courses started by the University are self -financed, whether
adequate number of eligible per manent faculties are available?
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It is a paid course. It is optional for the UOM -affiliated colleges to conduct
the course at their respective institutions. It is an autonomous value -added
course independent of the student -teacher ratio and may be delivered by
guest faculty from HEIs and Industry.
5 To give details regarding duration of the Course and is it possible to
compress the course?
Duration: 30 Hours
This is the minimum duration required and not recommended for further
compression.
6 The intake capacity of each course and number of admissions given in
the current academic year 2022 -23?
Batch size should be ideally restricted to maximum 45 to increase the
effectiveness of the course. The course is proposed to be introduced from
academic year 2022 -23
7 Opportunities of employability / employment available after
undertaking these courses.
Clinical Data management, Pharmacovigilance/drug safety in BPOs,
Pharmaceutical companies, Contract Research Organizations (CROs), etc.
Signature –
Dr.SupriyaShidhaye,
Chairman, Ad -hoc Board of Studies in Pharmacy
Under the faculty of Scien ce and Technology