What is it? Why is it important?
- The study database (eCRF) is ready for data entry, with staff given personalised 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
Data collection can only begin once participants have been adequately informed about the study, and have agreed to participate by signing the study ICF.
What do I need to do?
- Retrieve source-data
- Document corrections on pCRF
- Make certified copies
- Manage and file study documents
- 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)
As a SP-INV abstain from looking at or analysing the data during study conduct, as it carries a risk of corrupting the study. An exception is a planned interim analysis which is based on specifications given in the study protocol.
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, 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
- 5.5. Trial Management, data handling, and record-keeping