Research Data

Research data are submitted to the sponsor and/or analyzed by the Emory Investigator on paper case report forms (CRFs) or by electronic data capture (EDC). EDCs are software that stores research and patient data collected in clinical trials. EDCs are becoming the standard for Industry and DHHS-supported clinical trials because they offer quick access to data, security, accuracy, and query management. EDCs are also available for investigator-initiated clinical trials. Emory offers the REDCap platform for investigator-initiated studies.

Data Entry

  • EDCs are designed to imitate paper forms, capture clinical trial information, and promote data standards
  • Data must be entered by authorized site personnel, as documented on the delegation of authority log
  • EDC entry must be consistent with source data from the participant’s medical record, source worksheets, and/or participant questionnaires
  • If the study uses paper CRFs, entries must be legible
  • Abbreviations and acronyms should be avoided unless they are standard medical abbreviations or known to be acceptable
  • Complete the header information on each page consistently. Complete every field on each CRF page, unless otherwise indicated. If something is not done, unknown, or not applicable make a comment (ND/UK/NA) and strike through the field so it is obvious the item has not just been missed.
  • Do not write outside of the designated boxes. Write comments on the comments section/page.
  • Complete each box using leading zeros
  • To amend incorrect data on a CRF page:

    • Score through the error with a single line,
    • Do not obscure the original entry (do not use correction fluid),
    • Write the correct data nearby, and
    • Initial and date each change.
  • Do not record incomplete dates (e.g., if the month and year are known, but not the day, record- 04/NK/05).
  • Record dates in the requested format (e.g., 11/04/05; 04/11/05; 11 APR 05; 11 APR 2005)
  • Use the correct or consistent unit for weight, height, lab results, etc.
  • Ensure AEs are consistent through visits, as applicable. If events are new at cycle/visit 1 but continue through cycle/visit 2, make sure it is documented at cycle/visit 2 as well. This can be best accomplished by recording AEs on an AE log which includes start date, stop date, grade of AE, attribution (relation to study drug), and action taken. Ensure that a qualified study team member, who has been given AE activity on the delegation of authority log, assesses and documents the clinical significance, grade, and attribution of the AE.
  • If a medication was given for an adverse event, document the drug, start/stop dates, and response

Source Data Verification

The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data.  This can be accomplished and documented either electronically or by paper. For electronic data capture, the sponsor may ask the PI to electronically sign each page or multiple pages at defined periodic time points. Some sponsors may have the PI sign an attestation page at the end of EDC completion, which will document the PI’s verification that the data are complete and accurate. For paper CRFs, the PI may sign and date each page or sign an attestation page at the completion of all CRFs for a certain participant or entire study.

Data Review and Queries

Sponsors periodically review data in the EDC, termed “centralized monitoring,” during the study to verify and analyze data. When sponsors suspect an error with data entry, they will issue a query for the study team to review, clarify, and/or correct data. Sponsors send queries by email, notification in the EDC, or through a sponsor system requiring study teams to log-in to view and correct queries. Sponsors have time requirements resolving data queries to ensure high quality data. 

EDC and Source Documentation Organization

Data should be entered promptly after the research or clinical encounter. A backlog of EDC entry compromises data integrity.

Emory requires research records be stored for 10 years after study closure or termination. For studies involving children, in-vitro specimens, or pregnant women, Emory requires storage of research records for 25 years.  The FDA requires that investigators and sponsors retain records for 2 years following the date a marketing application is approved for the drug/device for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. The sponsor may have further record retention policies. A good rule of thumb is to store the records for the longest period of time across Emory, FDA, and the sponsor.

Abbreviations

CRF: case report form

LE: late entry

NK: not known

ND: not done

NA: not applicable

NAD: no abnormalities detected

AE: adverse event

SAE: serious adverse event

UNK: unknown

References

Emory University Records Management PolicyandInternational Conference of Harmonization, Efficacy Guidelines, Good Clinical Practice