Conduct↦Monitoring↦Routine Monitoring Visit↦Conduct
What is it? Why is it important?
Routine Monitoring Visit(s) (RMV) are carried out after the Site Initiation Visit (SIV) and until the end of the study, or the end of participant recruitment.
In order for the RMV to take the place, the study site must provide the monitor with access to required documents (paper and electronic) needed to evaluate compliance (e.g. access to the study database, ICFs, source data, patient files).
Compliance is assessed according to specifications given in the study protocol, applicable Swiss laws (e.g. HRA, ClinO, ClinO-MD, HRO, Data Protection (FADP)) and regulations (e.g. principles of ethics, ICH GCP, ISO 14155).
Issues / findings management include to:
- Check whether outstanding issue(s) / findings from previous RMVs were correctly resolved
- Document remaining issues / findings in a monitoring report.
- Provided the site with suggestions and a defined timeline needed to resolve open issues
During RMVs, Source Data Verification (SDV) is a key monitoring activity further under More.
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 Monitoring Plan (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 Ethics Committee (EC) if applicable RA (e.g. Swissmedic) approved documents are used in the study
- The therapeutic product under investigation (IMP / IMD) is correctly stored and accounted for (access protected, temperature control, product accountability-log)
- The site visit log is signed by the monitor and site staff
While conducting the study, it may be necessary to adapt documents or issue an amendment (e.g. protocol amendment, ICF and PIS amendment).
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R3) – see in particular guidelines
- Glossary: definition monitoring
- Glossary: definition monitoring plan
- 3.10.1.3 Risk control
- 3.11.4 Monitoring
- 3.11.4.5 Monitoring activities
- 3.11.4.5.1 Communication with parties conducting the trial
- Appendix C. Essential documents for the conduct of a clinical trial
ICH E8 – see in particular guideline
- 6.1 Study conduct
- 6.2.1 Safety monitoring
ISO 14155 Medical Device – see in particular sections (access liable to costs)
- 5.8 Informed Consent
- 10.8 Safety Reporting
- 9.2.4.5 Routine on-site monitoring visits
ISO 20916 – In Vitro Diagnostica (access liable to costs)
ISO 20387 – Biobanking (access liable to costs)
Swiss Law
HRA – see in particular
- Art. 1 Purpose
ClinO – see in particular articles
- Art. 5 Good Clinical Practice
- Art. 29 Changes (EC point of view)
- Art. 29 Changes (RA point of view)
ClinO-MD – see in particular articles
- Art. 3 Applicable provisions
- Art. 15 Modifications (EC point of view)
- Art. 20 Modifications (RA point of view)
HRO – see in particular
- Art. 2 Applicable provisions