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REPRIEVE Source and Monitoring

REPRIEVE-Electronic Source

For the REPRIEVE study a new EDC (electronic data capture) system, OpenClinica is being used. The system allows for different options to be utilized for entering and managing data. The system will also allow monitors to have direct access to the study visit data once it is entered into OpenClinica by the site staff. Our plan is to try to conduct some of the monitoring visits as “remote visits” where the monitors will review the PID data via computer from their offices and flag data that requires clarification or correction. While the monitors will be able to review the data electronically there is still a GCP requirement for adequate source data. Since many clinical investigations are now using new technology and computerized systems the FDA published a guidance document in May 2007, Guidance for Industry: Computerized Systems Used in Clinical Investigations. We would like to provide some guidance to sites regarding the requirements for source documentation, what monitors will be looking for and how this study will be monitored.

Source data and source documentation must still meet the same requirements of data quality (e.g. attributable, legible, contemporaneous, original and accurate) as would be expected when using paper records. For the REPRIEVE study, participant data may be entered directly into OpenClinica via the site’s computers. In this case, the electronic record is the source document if the original observations are entered directly into the computerized system. If the site staff first record participant information in a clinic chart, institution medical record or any other hardcopy method (paper notes etc.) and then enters the data into OpenClinica, the clinic chart, medical record or hardcopy is the source document.

Monitoring REPRIEVE

The investigator must retain records as required under 21 CFR 312.62, 511.1(b). This requirement applies to the retention of original source document or a copy of the source document.

As referenced in sections 5.18.1.b, 5.15.1 & 6.10 of the ICH Guidelines for Good Clinical Practice E6, the trial sponsor and investigator are required to ensure that monitors are provided direct access to source data consisting of original documents, data and records (source documentation). In the case where source data is collected electronically through direct entry, monitors will access and review source data directly from the electronic database utilized. Providing the monitor direct access to the electronic capture method ensures that contemporaneous and accurate data are reviewed. Monitoring from a printed version of an electronic database is not recommended as there is very often no way to guarantee that data in the electronic version has not been revised between the time of printing and the time when monitoring of that data is finalized. Besides a risk to participant safety and data integrity this could also result in multiple printouts of the same data being required.

In accordance with the definition of original data, the monitor will apply vigilance to ensure that the electronic database is being used as the first point of entry for all applicable data points. Wherever data is initially collected in another format, this becomes the original data and therefore monitoring of those documents will be required. It is a recommendation for sites to retain a source document SOP defining data collected directly via electronic medium vs. data collected in any other manner as defined in ICH E6 1.52 (Source Documents). Clinical Research Site staff are advised to be thoughtful of the logistics, practicalities and infrastructure required for entering data directly in an electronic database prior to compiling such a document. This document would provide guidance to site staff, monitors, IRB/EC, auditors or other entities appropriately authorized to view source data directly.

Helpful Definitions

Original Data:  For the purpose of this guidance, original data are those values that represent the first recording of study data. FDA is allowing original documents and the original data recorded on those documents to be replaced by copies provide the copies are identical and have been verified as such.

Source Documents:  Original documents and records including, but not limited to, hospital records, clinical and office charts, laboratory notes, memoranda, subject’s diaries or evaluation checklists, pharmacy dispensing records, recorded date=a from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, z-rays, subject files and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in a clinical trial.

Direct Entry:  Direct entry is recording data where an electronic record is the original means of capturing the data. Examples are the keying by an individual or original observations into a system, or automatic recording by the system of the output of a balance that measures subject’s body weight.


Guidance for Industry: Computerized Systems Used in Clinical Investigations, U.S. food and Drug Administration, May 2007