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

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 (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.

Checkin 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

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 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 approved and current documents are used in the study
  • IMP/MD are correctly stored and accounted for

More

While conducting the study, it may be necessary to adapt documents or issue an amendment (e.g. protocol amendment, ICF and PIS amendment).

Procedures include:

  • A significant amendment to a document must be approved by EC and, if applicable, by RA 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

References

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
  • 9.2.4.5 Routine on-site monitoring visits
Abbreviations
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GCP – Good Clinical Practice
  • IC – Informed Consent
  • ICF – Informed Consent Form
  • ISF – Investigator Site File
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • MP – Monitoring Plan
  • RA – Regulatory Authorities
  • RMV – Routine Monitoring Visit
  • SD – Source Data
  • Site-INV – Site-Investigator
  • SIV – Site Initiation Visit
  • TMF – Trial Master File
Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Conduct
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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