Clinical data management involves collecting trial data according to regulatory standards. There are three main types of data management systems - pure paper-based, electronic-based, and hybrid systems. A recent study investigated the challenges of mixed-method telephonic data collection for assessing the mental health of healthcare workers during the COVID-19 pandemic in India. While telephonic interviews presented difficulties, the authors concluded it could serve as an alternative to in-person data collection when used carefully.

2. CONTENTS
• INTRODUCTION
• COMMUNICATION
• DATA COLLECTION
• PURE PAPER BASED SYSTEM
• ELECTRONIC BASED SYSTEM
• HYBRID SYSTEM

3. INTRODUCTION
• Clinical data management (CDM) is the process of collecting and managing research
data in accordance with regulatory standards to obtain quality information that is
complete and error-free.
• The goal is to gather as much of such data for analysis as possible that adheres to federal,
state, and local regulations.
• Various procedures in CDM including Case Report Form (CRF) designing, CRF
annotation, database designing, data-entry, data validation, discrepancy management,
medical coding, data extraction, and database locking are assessed for quality at regular
intervals during a trial.(1)

5. DATA COLLECTION
• Clinical data consist of information ranging from determinants of health and
measures of health and health status to documentation of care delivery. These data
are captured for a variety of purposes and stored in numerous databases across the
healthcare system.
• Data collection for clinical research involves gathering variables relevant to
research hypotheses. These variables ('patient parameters,' 'data items,' 'data
elements,' or 'questions') are aggregated into data-collection forms ('Case Report
Forms' or CRFs) for study implementation.(2)

6. DATA COLLECTION
• Data management system depends on the data collection method.
• Data collection methods are of three types:-
 Pure paper based system
 Electronic based system
 Hybrid system
• COMMUNICATION:- It is the process of sending information from one place to another
place or one person to another by means that enables the sender to send the information
to intended recipients. E.g.: direct meetings, mail carrier, telephone, fax, email, websites,
video conferencing and etc.

7. PURE PAPER BASED SYSTEM
• Paper-based case report forms (CRF) are the most widely used form of data
collection in field-based research studies. In this approach data collected are
recorded on paper and subsequently digitalized.(3)
 There are three processes in paper based system.
1. Suitability and hardware/software requirements
2. Design and implementation
3. Managing data

8. Suitability and hardware/software
requirements
Design and implementation Managing data
• A major drawback is that
participating sites do not have
real-time access to their data
because no database is created
locally.
• The type of hardware and
software used is determined by
the configuration of the
centralized computer. The most
commonly used platforms
include Open VMS, Unix, or
PC, and one of the most widely
used software packages is
SAS®.)(3)
• Paper-based data collection
systems use paper forms that
can be designed using any
graphical or word processing
software. Like any other type
of data collection system,
forms should be finalized
before the data collection
phase begins.
• Each collectable data element
exists in a specific record of
a specific form and can be
further identified by the
column or space number(s)
within the record.
• Paper-based data
collection systems are
inefficient in that they
require large data editing
overhead. Personnel at the
central location must
perform visual inspections
of forms Data entry staff
enter electronic text files
with double key data entry
software.
• Then these files are
released to the trial data
management programmer.

9. ELECTRONIC-BASED SYSTEMS
• Electronic Data Capture (EDC) system is software that stores patient data collected
in clinical trials. Data is typically first recorded on paper and is then transcribed into
the system and saved in an electronic case report form (eCRF).
• There is a difference between EDC and eCRF. Electronic data capture, EDC, is a
software used for collecting clinical trial data. An electronic case report form, or
eCRF, is a digital (usually web-based) questionnaire for collecting data about a
study participant.(4)

10. ELECTRONIC-BASED SYSTEMS
1. Centralized system
2. Distributed system
3. Wireless system
4. PDF- based system
5. Web based system
6. Direct system

11. HYBRID SYSTEM
• Hybrid systems are those systems that employ various strategies to collect data. In
such systems, data may be collected on paper forms as patient self administered
questionnaires, while additional data may be downloaded from centralized
databases.(3)
1. Paper Data Collection with Centralized Interactive Data Entry
2. Paper Data Collection with Centralized Batch Data Entry
3. Paper Data Collection with Direct Data Transfer to Centralized DMS
4. Integration of Distributed Systems with Remote Servers over the Internet

12. PAPER DATA COLLECTION WITH CENTRALIZED
INTERACTIVE DATA ENTRY
Corrections are then applied to the data base and added to the audit trail.
The first data coordinator checks and rectifies these discrepancies.
Compares the entries against the paper forms, flagging any discrepancies
Data coordinatiors enters them directly into a centralized data management system
Shipped to the coordinating centre
Data are collected on paper forms

13. PAPER DATA COLLECTION WITH
CENTRALIZED BATCH DATA ENTRY
• Another approach is the use of fax transmission to a dedicated computer equipped
with software such Teleform software that can be customized to fit the needs of the
clinical trial.
• Scannable forms are designed with specialized software and distributed to the
participating sites to the complete.
• Completed forms are faxed to central locations.(3)

14. PAPER DATA COLLECTION WITH DIRECT DATA TRANSFER TO
CENTRALIZED DMS & INTEGRATION OF DISTRIBUTED SYSTEMS WITH REMOTE SERVERS
OVER THE INTERNET
• Scannable forms are designed with
specialized software and distributed to
participating sites. SCs are equipped
with fax machines to fax the completed
forms to the central location. Another
approach is the use of scanners to scan
completed forms, using special software
to create an image of the paper forms.
All participating sites must have an Internet connection
It requires the ability to constantly be connected to the
Internet
The Internet connection makes it less portable
It generates a large amount of network traffic
It creates difficult issues of data validation and
data integrity
There can be browser incompatibilities.

15. ARTICLE:- 1 Challenges and opportunities in mixed method data collection on
mental health issues of health care workers during COVID-19 pandemic in India
• Ragini Kulkarni et al. 2022 were described the key challenges and opportunities of
mixed method telephonic data collection for mental health research using field
notes and the experiences of the investigators in a multicenter study in ten sites of
India.
• The study was conducted in public and private hospitals to understand the mental
health status, social stigma and coping strategies of different healthcare personnel
during the COVID-19 pandemic in India.
• Qualitative and quantitative interviews were conducted telephonically. The
experiences of data collection were noted as a field notes/diary by the data
collectors and principal investigators.(5)

16. • The interviewers reported challenges such as network issues, lack of transfer of
visual cues and sensitive content of data. Although the telephonic interviews
present various challenges in mixed method data collection, it can be used as an
alternative to face-to-face data collection using available technology

17. CONCLUSION:-
• It is important that the
investigators are well trained
keeping these challenges in
mind so that their capacity is
built to deal with these
challenges and good quality
data is obtained.

18. REFERENCES
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research: an overview. Indian journal of pharmacology. 2012 Mar;44(2):168.
2. Richesson RL, Nadkarni P. Data standards for clinical research data collection forms: current
status and challenges. Journal of the American Medical Informatics Association. 2011 May
1;18(3):341-6.
3. Willy J. Computer Applications in Pharmaceutical Research and Development (Wiley Series
in Drug Discovery and Development).2006;593-632.
4. Rorie DA, Flynn RW, Grieve K, Doney A, Mackenzie I, MacDonald TM, Rogers A.
Electronic case report forms and electronic data capture within clinical trials and pharmaco
epidemiology. British journal of clinical pharmacology. 2017 Sep;83(9):1880-95.
5. Kulkarni R. Challenges and opportunities in mixed method data collection on mental health
issues of health care workers during COVID-19 pandemic in India. International Journal of
Research in Medical Sciences. 2022 Apr;10(4):838.