What is it? Why is it important?

Source Data (SD) is the location where data that is being used originates from, such as original records of findings and observations. In other words, where data is first born or where physical information is first digitised.

In studies, SD are all information in original records and certified copies of original records of clinical findings, observations, or other study activities necessary for the reconstruction and evaluation of the study. Thus, SD provide the information needed to answer a study question(s).

Example of SD:

  • Hospital / medical records
  • Laboratory reports
  • Participant diaries and questionnaires
  • Evaluation checklists
  • Pharmacy dispensing records
  • Data digitised from automated instruments
  • Certified copies of microfiches, photographic negatives, microfilm, magnetic media, x-rays

More

SD is not only study-specific, but is also part of daily clinical practice needed during the optimal management of disease.

Any data collected from study participants require initially be approved by EC/RA. Thus, all data that is collected during study conduct must be listed and described in the study protocol.

Once approved:

  • Only data listed in the study protocol can be collected
  • The collection of SD not specified in the study protocol, require a prior protocol amendment and prior EC/RA approval

What do I need to do?

As a SP-INV or Site-INV:

  • Make a list (called SD location form) of any collected SD (based on study protocol)
  • Define SD location to ensure correct data retrieval (e.g. laboratory reports, patient file)
  • Ensure SD:
    • Is entered in a timely manner in the CDMS (eCRF/pCRF) of the study
    • Remains at the site and is not externally transferred or accidently destroyed
  • Provide access to the study CDMS including its SD during study monitoring

Handling of SD:

  • Date and sign study related SD
  • File any collected SD according to SD the correct location in the PF (e.g. lab reports)
  • In the event information is entered by hand, ensure data is correct, complete and legible
  • In paper PF, date and sign changes and ensure that original entries remains legible

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.51 Source Data
  • 1.52 Source Documents
  • 4.9.0 Source Data Records and Reports
Abbreviations
  • CDMS - Clinical Data Management System
  • CRF – Case Report Form (p – paper; e – electronic)
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • eCRF – electronic Case Report Form
  • pCRF – Paper Case Report Form
  • PF – Patient File
  • SD – Source Data
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Documents ↦ Required Documents ↦ Source Data
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Documents ↦ Required Documents ↦ Source Data

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