Data collection and management in clinical trials are crucial for ensuring the accuracy, integrity, and reliability of study findings. Here are some best practices for data collection and management in clinical trials: Standardized Data Collection: Use standardized data collection tools, such as electronic case report forms (eCRFs), to ensure consistent and uniform data capture across study sites. Clearly define data fields, formats, and coding conventions to minimize variability and errors. Training and Standard Operating Procedures (SOPs): Provide comprehensive training to study personnel on data collection procedures, including proper documentation, data entry, and quality control measures. Develop and implement SOPs that outline data collection, handling, and storage processes. Source Data Verification (SDV): Perform regular source data verification to ensure the accuracy and completeness of data. Compare data entered in the eCRFs with original source documents (e.g., medical records, laboratory reports) to identify discrepancies and resolve any inconsistencies. Data Quality Checks: Implement automated data quality checks to identify potential errors, outliers, and inconsistencies in the data. Range checks, logic checks, and consistency checks can help identify data entry errors or missing data points. Data Security and Confidentiality: Implement robust data security measures to protect participant confidentiality and comply with data protection regulations. Use secure servers, encryption techniques, and access controls to prevent unauthorized access and ensure data privacy. Data Monitoring and Audit Trails: Establish a data monitoring plan to regularly review and validate data for accuracy and completeness. Maintain an audit trail that tracks any changes made to the data, including the date, time, and reason for modifications. Data Backup and Storage: Implement regular data backup procedures to prevent data loss. Store data securely and ensure appropriate backup storage to mitigate risks associated with data corruption or system failures.

1. Welcome
BEST PRACTICES FOR DATA COLLECTION IN DECENTRALIZED
CLINICAL TRIALS
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Student Name: Divya Nagurtha
Qualification: Pharm. D
Student ID: 066/042023

2. Index
WHAT ARE DECENTRALISED CLINICAL TRIALS?
OBJECTIVES
BEST PRACTICES FOR DATA COLLECTION IN DCT
CONCLUSION
REFERENCES
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3. WHAT IS DECENTRALIZED CLINICAL TRAILS ?
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• Decentralized Clinical trials (DCT) are clinical trials that use digital technologies and
remote participants to conduct clinical research outside of traditional clinical
settings ·
• Data is collected remotely from participants often from their homes using various
digital technologies, including telemedicine software, wearables, and mobile
applications.
• DCTs comply with Good Clinical Practice (GCP) guidelines, ensuring patient safety
and data integrity.
• They have become increasingly popular in recent years, especially during the
COVID-19 pandemic, which led to a shift towards remote clinical trials due to the
limitations in-person visits.

4. OBJECTIVES:
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The objectives of decentralized clinical trials(DCT’’s)are several, including :
1. Increased convenience for patients.
2. Reduced costs and time.
3. Better patient retention and recruitment.
4. Enhanced patient experience.
5. Better data quality.
6. Increased diversity of patient populations.
Overall, the main objective of DCT’s is to increase patient access and engagement to
improve clinic research efficiency and results while minimizing the burden on
patients and researches.

5. BEST PRACTICES FOR DATA COLLECTION IN
DECENTRALIZED CLINICAL TRAILS :
 Use a variety of digital technologies
 Ensure adequate training of investigators and patients.
 Ensure data, privacy and security
 Ensure data consistency.
 Monitor adherence to data collection protocols.
 Plan for data quality and integrity.
 Use real–time data monitoring.
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6.  Use a variety of digital technologies :
DCTs utilize a range of digital technologies to collect data remotely. These include
wearable mobile applications and telemedicine software. Using a variety of
technologies increases the accuracy and completeness of data collected from patients.
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7.  Ensure adequate training of investigators
and patients:
Since most DCTs are conducted remotely, it is essential to provide
investigators and study participants with thorough training on the use
of digital technologies and any study procedures. This can be done
using online training modules or virtual training sessions
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8. 8
 Ensure data privacy and security:
Data privacy and security is critical in DCTs. Ensure that patients data is protected by
using secure data trains for platforms, encryption technologies, and maintain
adherence to privacy laws and regulations.

9. 9
 Ensure data Consistency:
Consistency of data collected is key in DCTS. To ensure this standard operating
procedures (soft) for all data collection procedures should be established and
followed by all study personnel.

10. 10
 Monitor adherence to data collection
protocols:
Regular monitoring and auditing are crucial to ensure consistency in data collection.
This can be done remotely, using secure video conferencing technology.

11. 11
 Plan for data quality and integrity
Data quality and integrity should be considered throughout the study design. This
should include validation of digital data collection instruments and regular review of
data collected to ensure accuracy.

12. 12
 Use real-time data monitoring:
Real-time data monitoring and alerting can help identify adverse events or other issues
as they occur, allowing for early intervention and improved outcomes.

13. 13
 CONCLUSION:
In conclusion decentralization provides a more patient focused and cost-effective
approach to clinical trials. It decentralizes the clinical trail process by shifting some of the
burden to the local community and the existing healthcare system, making trials more
accessible to a border, more diverse patient population and potentially accelerating
overall clinical research progress.
By following these best practices, study teams can ensure that data collected in DCT’s is
accurate, reliable and secure. They can also improve efficacy and patient outcomes in
clinical trials.

14.  REFERENCES:
https://www.pharmoutsourcing.com/Featured-Articles/592076-Best-Practices-for-Data-Collection-in-
Decentralized-Clinical-Trials/
https://www.frontiersin.org/articles/10.3389/fpubh.2022.1081150/full#:~:text=Decentralized%20clinica
l%20trials%201%20
https://mdgroup.com/blog/why-decentralisation-is-the-future-of-clinical-trials/
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15. ThankYou!
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