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.

  • 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?


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


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 CTU can support you with experienced staff regarding this topic


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
  • Routine on-site monitoring visits


Swiss Law

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)
  • CDMS - Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GCP – Good Clinical Practice
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IC – Informed Consent
  • ICF – Informed Consent Form
  • ISF – Investigator Site File
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISO – International Organisation for Standardisation
  • MP – Monitoring Plan
  • PIS – Participant Information Sheed
  • RA – Regulatory Authorities
  • RMV – Routine Monitoring Visit
  • SDV – Source Data Verification
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor Investigator
  • SIV – Site Initiation Visit
  • TMF – Trial Master File
Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Conduct

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Conduct

Please note: the Easy-GCS tool is currently under construction.