What is it? Why is it important?
- Outstanding issue(s) from previous RMVs are rechecked in subsequent visits until they are resolved
- The site provides the monitor with all required documents necessary to evaluate compliance with the study protocol, GCP, and applicable laws and regulations
- At the end of each RMV, findings are documented in a monitoring report, and the site visit log is signed by the monitor and site staff
Source Data Verification (SDV) is an important monitoring activity and is explained further under More.
SDV is an important monitoring activity and can only be performed at the study site.
- Source data is contained in source documents, which are the first place where the original information is initially recorded. Thus, source data is the source from which data is retrieved and entered in the eCRF of the study database / CDMS (e.g. lab reports, X-rays, questionnaires, score calculations)
- Data that has no source but is directly entered into the study database must be defined in the study protocol
- During SDV, the monitor checks whether data entered into the eCRF of the study database is traceable and correct based on its original source
- Data entered into the study database will be used to statistically evaluate the study by asking questions such as; has the planned intervention been successful?
- Only truthful and correct data will be able to provide the necessary confidence in study results
Prior to viewing any data pertaining to a participant, the monitor must ensure that the participant has agreed to participate in the study and that the IC process has been correctly followed.
Checking for correctly implemented IC procedures include that:
- The participant has personally dated and signed the ICF
- The Site-INV has personally dated and signed the ICF
- The ICF used is current and has been approved by the EC
- All study procedures are performed only after the participant has signed the ICF
- The participant did receive a copy of the PIS and the signed ICF
What do I need to do?
If you are the study monitor, perform monitoring tasks according to the MP
If you are an Site-INV, ensure that:
- Participant consent is available (signed and dated ICF), as only data from consented participants can be checked by the study monitor
- The eCRF of the study database (CDMS) is up to date and consistent with the source data
- Safety reporting is done in a timely and correct manner
- Staff is trained on tasks and responsibilities
- Document filing is up to date (e.g. ISF and TMF)
- Only EC if applicable RA (e.g. Swissmedic) approved and current documents are used in the study
- IMP/IMD are correctly stored and accounted for
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
- 4.8 Informed Consent of Trial Subjects
- 4.11 Safety Reporting
- 5.18 Monitoring activities
- 6.10 Access to source data / documents
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 5.8 Informed Consent
- 10.8 Safety Reporting
- 188.8.131.52 Routine on-site monitoring visits
ClinO – see in particular article
- Art. 29 Changes (EC point of view)
- Art. 29 Changes (RA point of view)
ClinO-MD – see in particular article
- Art. 15 Modifications (EC point of view)
- Art. 20 Modifications (RA point of view)