CLINICAL DATA COLLECTION AND MANAGEMENT.pptx

Computer aided drug development seminar topic related ppt.

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

2. 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)

3. 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)

4. 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.

5. 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. Suitability and hardware/software requirements Design and implementation Managing data

6. 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.

7. 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)

8. ELECTRONIC-BASED SYSTEMS Centralized system Distributed system Wireless system PDF- based system Web based system Direct system

9. 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) Paper Data Collection with Centralized Interactive Data Entry Paper Data Collection with Centralized Batch Data Entry Paper Data Collection with Direct Data Transfer to Centralized DMS Integration of Distributed Systems with Remote Servers over the Internet

10. PAPER DATA COLLECTION WITH CENTRALIZED INTERACTIVE DATA ENTRY

11. 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)

12. 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.

13. 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)

14. 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

15. 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.

16. REFERENCES Krishnankutty B, Bellary S, Kumar NB, Moodahadu LS. Data management in clinical research: an overview. Indian journal of pharmacology. 2012 Mar;44(2):168. 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. Willy J. Computer Applications in Pharmaceutical Research and Development (Wiley Series in Drug Discovery and Development).2006;593-632. 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 . 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.