Conduct↦Monitoring↦Routine Monitoring Visit↦Conduct
What is it? Why is it important?
Routine Monitoring Visit(s) (RMV) are carried out after the SIV and until the end of the study, or the end of participant recruitment.
- 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 (SD) verification is an important monitoring activity and is explained further under More.
Source Data (SD) verification is an important monitoring activity and can only be performed at the study site.
- SD consists of those documents in which the original information was initially recorded. Thus, SD 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 SD but is directly entered into the study database must be defined in the study protocol
- During SD verification, the monitor checks whether data entered into the eCRF of the study database is traceable and correct based on its original source (SD)
- 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:
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 SD
- 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
While conducting the study, it may be necessary to adapt documents or issue an amendment (e.g. protocol amendment, ICF and PIS amendment).
- A significant amendment to a document is approved by EC and, if applicable, by RA (e.g. Swissmedic) before it is implemented
- The document with its amended activities or procedures may only be implemented after it has been approved. Exceptions are changes that must be implemented due to safety concerns, as these changes must be implemented immediately or as soon as possible by the Site-INV. Protocol changes due to safety issues must be discussed with the SP-INV and reported to the EC and RA
- Outdated documents are marked as such and are no longer valid. Nonetheless, they must remain filed in the ISF or TMF in order ensure traceability
- New documents are given a new and subsequent version number
- All staff must be informed of any amendments to documents and given additional training, if necessary
As some study documents require EC and if applicable also RA approval, it is important to make sure that only approved and current versions of the documents are used. Checking that only current and approved documents are use in the study is an important monitoring activity.
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
- 184.108.40.206 Routine on-site monitoring visits