FDA regulations on eClinical trials

The following general guidelines are proposed by FDA in reference in Computerized systems in clinical trials, the complete document is available at http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm

A. Each study protocol should identify at which steps a computerized system will be used to create, modify, maintain, archive, retrieve, or transmit data.

Comment : This means that the study protocol has to receive input from the data manager. Most of the companies include these steps as SOPs so that they can be referenced in the study protocol.

B. For each study, documentation should identify what software and, if known, what hardware is to be used in computerized systems that create, modify, maintain, archive, retrieve, or transmit data. This documentation should be retained as part of study records.

Comment : This level of detail is not mandatory, and is often missed out in most study protocols.

C. Source documents should be retained to enable a reconstruction and evaluation of the trial.

Comment : This requirement is fulfilled via a Audit trial so that FDA/ independent audits can be performed.

D. When original observations are entered directly into a computerized system, the electronic record is the source document.

Comment : The specific condition where this rule will not apply is for lab data, the source data is obtained electronically from the lab. The data is then batch loaded into the CDM system, still the source data is the lab data.

E. The design of a computerized system should ensure that all applicable regulatory requirements for recordkeeping and record retention in clinical trials are met with the same degree of confidence as is provided with paper systems.

Comment : 21 CFR Part 11 and ER/ES are two common regulatory requirements. The "degree of confidence" is set via a validation process for each CDM system.

F. Clinical investigators should retain either the original or a certified copy of all source documents sent to a sponsor or contract research organization, including query resolution correspondence.

Comment : Though this sounds simple, it is complicated for investigators to maintain a source data archive.

G. Any change to a record required to be maintained should not obscure the original information. The record should clearly indicate that a change was made and clearly provide a means to locate and read the prior information.

Comment : All updates on source data will include a reason for change, data and time of change, person initiating the change, data value before change and data value after change. Sometimes the change in data may require sign-off by a study manager.

H. Changes to data that are stored on electronic media will always require an audit trail, in accordance with 21 CFR 11.10(e). Documentation should include who made the changes, when, and why they were made.

Comment : Refer to above

I. The FDA may inspect all records that are intended to support submissions to the Agency, regardless of how they were created or maintained.

Comment : Refer to above

J. Data should be retrievable in such a fashion that all information regarding each individual subject in a study is attributable to that subject.

Comment : Refer to above

K. Computerized systems should be designed: (1) So that all requirements assigned to these systems in a study protocol are satisfied (e.g., data are recorded in metric units, requirements that the study be blinded); and, (2) to preclude errors in data creation, modification, maintenance, archiving, retrieval, or transmission.

Comment : Refer to above

L. Security measures should be in place to prevent unauthorized access to the data and to the computerized system.

Comment : Refer to above