What is it? Why is it important?
- The database (eCRF) is ready for data entry with staff given individual access rights (documented in a database access log)
- Required study material has been delivered to the study site such as:
- Staff is trained on study tasks and individual responsibilities
Type of study data to be collected must be based on:
- Specifications given in the study protocol
- Source-data as defined in the study protocol and retrieved from participant’s
- Medical record
- Laboratory results
- Medical examinations
- Data provided by participants themselves (e.g. diary, questionnaire)
During study conduct the SP-INV must abstain from looking at or analysing study data, which carries the risk of corruption. An exception would be a planned interim analysis with its specifications documented in the study protocol
What do I need to do?
Ensure staff is trained on the collection and handling of study data such as:
- What source-data to collect and where this data can be retrieved
- How to document corrections on pCRF
- How to make certified copies
- How to file and store collected study documents (e.g. pCRF, participant questionnaires, medical interviews)
- Respect participant confidentiality:
- Use of participant code instead of personal identifiers
- Ensure restricted access to study hard copies (e.g. participant study folders and information)
Only once participants have been adequately informed about the study and agreed to participate by signing the study ICF can data collection begin.
For more information refer to Monitoring in this Study Guide.
When making corrections on pCRF, the following guidelines must be followed:
- Only study staff with documentation responsibilities can make corrections on study documents
- Original entries must remain legible
- Corrections are dated and initialised so as to trace any correction in case further clarifications are needed
In the electronic database (eCRF), entries and changes to data are automatically documented in the audit trail of the system.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.5. Trial Management, data handling, and record-keeping