Conduct↦Data Handling↦Data Entry↦Collection
What is it? Why is it important?
All collected study data must eventually be entered into the eCRF of the study. How data is collected (e.g. pCRF, laboratory print outs, participant questionnaire) or structured (number of visits, type of variables) depends on the set-up or design of the study.
Each participant and event (e.g. study visit) is given a unique identifier. This is important to:
- Maintain participant confidentiality
- Ensure any collected data is correctly allocated to the respective participant and applicable study visit
- Monitor individual study progress (e.g. participant recruitment)
- Build a data-set with variables that can be used for statistical analysis and the evaluation of your study
Database set-up or structure can include aspects such as:
- The inclusion of a pre-defined number of study visits
- A randomised study where participants are allotted to various possible treatment options
- Blinded interventions where treatment and placebo groups are coded and not-identifiable
- Standardised code libraries (e.g. ATC and MedDRA coding)
What do I need to do?
- Delegate data entry responsibilities to qualified staff
- Ensure staff is properly trained and have ongoing access to the eCRF of the study (e.g. individual access protected logins and passwords)
- Ensure a study DMan is available for questions or support (e.g. access, updates, system failure)
- Review the eCRF to confirm the accuracy of any entered data
Any data analysis performed by the SP-INV during study conduct can only be implemented based on specifications given in the study protocol (e.g. planned interim analysis).
Responsibilities of staff entering study data might include to:
- Compile, sort and if applicable compute source-data in preparation for data entry
- Review data for deficiencies or errors, including the correction of detected inconsistencies
- Enter data within given time limits, as it prevents belated queries and potential errors
- Ensure the exclusive use of personal logins. This guarantees the correct documentation of the audit trail, regarding what data was entered or changes by which staff member
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