This page is based on the European Medicines Agency Guideline on computerised systems and electronic data in clinical trials which, in turn, is based on ICH GCP and is therefore applicable in other jurisdictions such as Canada.

A procedure for electronically signing REDCap records can be found here.

Responsibility

• Investigators are responsible for data entered into eCRFs and other data acquisition tools under their supervision (electronic records).

• Adequate oversight by the investigator is a general requirement to ensure participant safety as well as data quality and integrity. Oversight can be demonstrated by various means, one of them being the review of reported data. 

• The signature of the investigator or authorised member of the investigator’s staff is considered as the documented confirmation that the data entered by the study staff and submitted to the sponsor are attributable, legible, original, accurate, complete and contemporaneous (ALCOA).

• Any member of staff authorised for sign-off must be qualified to do so.

Data Review

• It is important that the investigator review the data on an ongoing basis in order to detect shortcomings and deficiencies in trial conduct at an early stage, which is the precondition to corrective and preventive actions.

• It is essential that data are confirmed prior to interim analysis and the final analysis.

• Important data related to reporting of adverse events, adjudication of important events and endpoint data, data and safety monitoring board (DSMB) review, must be signed off in a timely manner.

• Data that are entered directly into the eCRF as source is particularly important. 

• The acceptable timing and frequency for sign-off needs to be defined and justified for each trial by the sponsor and should be determined by the sponsor in a risk-based manner. It will rarely be sufficient to just provide one signature immediately prior to database lock.

Recommendations

The following is a common approach for academic clinical trials.

1. Critical eCRF instruments should be reviewed and signed by the Qualified Investigator or sub-investigator, on an ongoing basis during the course of the study:

   • Eligibility and enrollment

   • Adverse events

   • Protocol deviations

   • Unanticipated problems

   • Other instruments deemed critical for the study

2. Wet signatures on paper CRFs or source documents may be appropriate. For example where eligibility is confirmed on paper prior to data entry into an electronic system.

3. Once an individual's participation in the study has ended their data should be reviewed (including any final data quality/management review) and signed off.

4. Once signed, data should be locked in order to prevent subsequent changes. Any such changes require the data to be reviewed and re-signed.

Making Best Use of Resources

The Qualified Investigator may delegate responsibility for data review and sign-off to suitably qualified staff. For critical instruments this would usually be a qualified physician. However, provided critical pages are signed by delegated, medically qualified staff, and since final sign-off certifies compliance with the ALCOA standard, final signoff may be undertaken by staff who are not medically qualified. This approach should be agreed with the Sponsor and documented in study procedures.