Electronic Data Capture & Remote Data Capture

Presented by:Pristyn Research Solutions

www.pristynresearch.com

• EDC

• RDC

• HISTORY

• EVOLUTION OF CLINICAL DATA CAPTURE

• CRITERIA FOR IDENTIFYING AN EDC

• REGULATORY GUIDELINE ON EDC

• EDC ISSUES

• VALIDATING ELECTRONIC SOURCE DATA

CONTENTS

EDC

Electronic data capture (EDC):

The process of collecting data into a permanent electronic form.

NOTE: “Permanent” in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail. See also data entry, data acquisition.

orA computerized system design for the collection of data in electronic format for use mainly in human trials.

FUTURE

History

Medical professionals

FDA

1990s web-based technology provided an opportunity to greatly improve the efficiency and accuracy of clinical data capture

(EDC) systems became available in the marketplace

&

Evolution of clinical data capture

• case report forms (CRF)

• 1980s, PCs were introduced to clinical trial use

• centralized process

• PCs at the investigator site allowed for the introduction of decentralized clinical data capture which became known as remote data capture (RDC).

• In RDC, computerized data was routinely transferred from each investigator site to the sponsor through some File Transfer Process (FTP)

• 1990s, web-based technology

HINDRANCE

A main hindrance in moving to more electronic source data is the belief that electronic data cannot be validated—a requirement of the FDA.

CRITERIA FOR AN EDC

Basic Criteria: Automated support:

• Data Collection,

• Data Extraction,

• Data Query,

• Data Validation,

• Data Manipulation,

• Data Sharing,

• Reporting, &

• HIPPA compliant

HEALTH INSURANCE PORTABILITY & ACCOUNTABILITY ACT-1996

Additional Advanced Criteria:

• Simple installation and study set up

• User friendly interface

• Flexible to meet variable research needs

• Electronic Patient Reported Outcomes (ePRO)

• Easy data exportation and database maintenance

• Hybrid capability to fit in paper sourced data

• Fast and satisfactory technical support and System upgrades

• Cost-effectiveness

REGULATORY GUIDELINE ON EDC:

• Qualification of central laboratories

• Verification of transfer and conversion processes of electronic data

• Verification of data by direct access

• Confirmation of received data

Qualification of central laboratories :

sponsor must conduct the system audit and/or assessment

SOP for all processes

CSV must be conducted in a planned manner.

Computer System Validation.

Verification of transfer and conversion processes of electronic data

• Specifications for electronic data capture should be established.

• Specifications on compatible software and hardware used for

electronic data capture should be defined.

• For testing purpose, the sponsor should receive and check the

electronic data of test results from the central laboratories.

• he sponsor should confirm the procedures to correct the test results

at the central laboratories, and check the process for obtaining

revised data.

Verification of data by direct access

patient IDs, dates, and other information between test reports and other source documents by direct access, in order to ensure authenticity of the data of each subject.

Confirmation of received data

Missing or redundant data.

Requirements of the GCP

Record Keeping:

Article 26 & Article 41

Data handling: using an electronic data processing systems (including remote electronic data systems)

Article 26, Paragraph 1-3

Article 26, Paragraph 1-3

Ensure and document that the electronic data processing systems fulfill the

sponsor’s established requirements for completeness, accuracy, reliability and

consistent intended performance (i.e. validation)

Maintain the operating procedures

Ensure that the systems are so designed as to permit data correction in such a

way that the data correction are documented and that all records of correction of

entered data remain undeleted as logs distinguishable to the inputter as well as to

the corrector (i.e. to maintain audit trail, input trail, and edit trail);

Maintain a security system for the data

Maintain the adequate backup of the data

Prepare and maintain a list of the individuals who are authorized to make data

correction, and

Keep the blinding in case of a blinded clinical trial.

Article 26, Paragraph 4 :

• Data converted during the processing, the sponsor should ensure that it is always Possible to compare the original data with the processed data.

Article 41 of the GCP :

• Record keeping at the site, including the source documents.

EDC issues

(1) FDA,

(2) Lack of mobile hardware, and

(3) Attitude.