Conduct↦Documents↦Required Documents↦Study Documentation
What is it? Why is it important?
During study conduct, SP-INV and Site-INV are responsible to maintain study oversight at all times. This is achieved through the ongoing documentation and update of study activities.
Study activities can be tracked in the following documents:
- PIS and ICF: inclusion of study participants
- Study logs: delegation of study responsibilities, inclusion of participants, etc.
- p/eCRF: documentation of collected study data
- Protocol Deviation: documentation of deviations to the study protocol
- Monitoring report: documentation of study compliance
- SAE and SUSAR forms: safety documentation
- Protocol: documentation of study management
- Amendment: documentation of changes to the study protocol, ICF, PIS, IB, etc.
- Staff trainings: competencies, responsibilities,
- IMP/MD handling: orders, inventory, shipments, storage conditions
- Communication: with partners, participants, study sites
- ASR: yearly safety documentation
An ongoing oversight and documentation of study activities ensure that study tasks remain correctly implemented, and that participant safety and data quality is guaranteed.
The SP-INV and Site-INV can delegate study tasks to qualified staff. However, overall study responsibility remains with the SP-INV and Site-INV, respectively.
What do I need to do?
- Check that study documentation is correct and current
- Regularly review the TMF or ISF to ensure all essential documents are filed
- Ensure data entry into the study CRF (e.g. CDMS) is done without delay
- Ensure monitoring findings that address documentation issues are quickly resolved
- Restrict the access to study documents to applicable study staff
As a SP-INV, you are responsible to implement a risk-based QMS. Within this context, various quality documents are implemented in the study (e.g. SOPs, WIs, study processes). Ensure quality documents remain current during study conduct. As required, perform quality reviews and implement improvement measures.
A good way to retain study quality and oversight is to plan regular team meetings, where problems can be identified early on and corrective measures can be discussed.
Document the meeting in a protocol and include:
- Identified problems or issues
- The implementation of corrective and or preventative measures, and the resolution of pending issues
- Adaptations regarding study processes and management
Documented protocol meetings:
- Are important reference documents for study staff, including meeting absentees
- Provide good evidence of study oversight in the event of an audit or inspection by RA (e.g. Swissmedic)
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
- 4.2.5 Supervision of delegated tasks
- 4.2.6 Qualification of delegated tasks
- 4.5 Protocol Compliance
- 4.11 Safety Reporting
- 8.3 During the Clinical Conduct of the Trial
ISO 14155:2020 Medical devices - see in particular section (access liable to cost)
- 10 Responsibilities of the principle investigator
ClinO – see in particular article
- Art. 5 Rules of Good Clinical Practice