Conduct↦Documents↦Required Documents↦Source Data
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 and RA (e.g. Swissmedic). 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?
- 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:
- 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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