What is it? Why is it important?
It is essential to guarantee that study data is collected and documented according to specifications given in the study protocol. In addition, compliance to study relevant SOPs and WIs addressing Data Management (DM) procedures ensure data of high quality.
Staff should be trained on:
- Procedures on how to collect study data (e.g. blood sampling and processing procedures, participant interviews)
- How to locate and access the source data of the study (e.g. knowledge regarding correct data source such as patient file, lab printouts)
- Data entry procedures (e.g. correct, complete and in a timely manner)
- Data quality requirements (e.g. quality assurance, monitoring)
What do I need to do?
- Defined SOPs/WIs and applicable guidelines before allowing staff to perform any DM tasks
- Ensure training is current and remains up to date during study conduct (e.g. new staff, shift in delegated responsibilities, changes / updates in DM procedures or risk control-measures)
- Document delegated DM tasks and responsibilities in a staff delegation-log, and trainings in an applicable training-log
In the event that participants are asked to enter data in a CRF, be it paper or electronic, they should receive appropriate training on how to do so. Both compliance as well as data quality is directly related to how well participant were trained on data collection and documentation procedures.
Training should be done:
- Prior to performing study delegated tasks
- By a qualified trainer or if manageable through self-training
- Either on-site, face-to-face, by telephone or other applicable mean
- During study initiation and repeated during study conduct especially in the event of poor compliance
- Whenever necessary and before changes to study conduct (e.g. novel staff, major changes of CDMS)
Both trainer and trainee date and sign the training log. By signing, the trainee confirms with his/her signature to have read and understood its content.
On the training log always refer to type of documents trained (e.g. SOPs, guidelines). Include document name, date, and version number.
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
- 2.8 Training
- 5.5. Trial Management, data handling, and record-keeping
ClinO – see in particular article
- Art. 6 Professional qualifications
HRO – see in particular article
- Art. 4. Professional qualifications