Development↦Management↦Study Documents↦Source Data
What is it? Why is it important?
Source Data (SD) is the original data derived from some primary source (e.g. lab report, participant questionnaire, medical examinations).
SD originate from:
- Information on participants based on existing medical records (e.g. medical history such as lab-, x-ray reports)
- Study specific information (e.g. study specific medical examinations, participant diaries and questionnaires)
- Is information needed in order to answer the study question
- Must be clearly documented and defined in the study protocol
- Are entered in the CRF eventually used for the statistical analysis of the study
Handling of SD is strictly regulated:
- The protocol describes the study and any SD needed to answer the study question
- SD should be attributable, legible, contemporaneous, original, accurate, and complete (ALCOAC)
- Changes to SD must be traceable, must not obscure the original entry, and must be explained if necessary (e.g. via an audit trail that documents what changes were made by who at what time)
- Any SD copies must be certified and follow a pre-defined certification process
- Direct access to SD must be guaranteed during study monitoring, audits, EC review, and regulatory inspection(s)
What do I need to do?
Based on the protocol, make a list and:
- Define required SD needed to answer the study question.
- Give a description of its variable(s) (e.g. vital scores, scales, various parameters)
- Define how variables should be specified (e.g. mg/ml, ml/sec., as a sum score, based on formula)
- Provide the source where SD is originally recorded (e.g. questionnaire, medical record, lab reports, patient diary, notes)
- Provide location where collected SD is stored (e.g. patient or study file)
For more information refer to Documents in this Study Guide.
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
ICH GCP E6(R2) – see in particular guidelines
- 1.51 Source documents definition
- 4.9.0 Records and Reports
- 6.10 Direct Access to Source Data / Documents
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 7.5.3 Source documents
- 7.8 Document and data control
- 220.127.116.11 g Monitoring