临研圈

Routine Monitoring visits are basically any visit that occurs after the site is initiated and up until the site is closed out. As monitors, we visit our sites periodically to ensure that they are compliant with all the regulations, subject safety is being adequately followed, data is being captured in a timely and reliable manner, the Investigational Product is being handled as per protocol and relevant regulations/guidelines, there are no significant deviations from the planned study protocol, all important study documentation is being generated and stored properly, and that the research site is adequately supplied in regards to lab kits and other pertinent study materials. The ultimate purpose of our job is to protect subject safety by monitoring the trial conduct for ICH/GCP compliance.

Here are 10 specific tasks that are routinely performed at these visits.

1: Informed Consent Form (ICF) review:

Ensuring that every subject was adequately informed and consented to the study before any study procedures were completed. Sometimes there are multiple versions of a consent due to a change in the facility address or the details of the protocol. Ensure that all subjects signed on an EC approved version. Proper consenting of subjects is critical to ensure the security and privacy of health data and that subjects are adequately informed of the study procedures, risks and, benefits.If the consent is not signed or properly completed inform the SC or investigator and do not review this subject’s medical chart until consent has been properly obtained.

2: Check for Serious Adverse Events (SAEs):

Per the guidelines, an SAE is any untoward event that results in death, prolonged or new hospitalization (longer than 24hrs), significant disability, or congenital anomaly (birth defect). If the event has not been reported, assist the investigator in doing so and inform the sponsor immediately.

3: Compare source documents to Case Report Forms:

Checking that the data in the chart matches the Case Report Forms. Determine whether or not CRFS being completed in a timely manner. You also want to verify that the source is complete, neat (all corrections must be compliant with the regulations – white-out is not OK), attributable (who wrote it? Is it initialed and dated), contemporaneous (was it written at the time the procedure was completed?), valid (is the data collected even possible?).

4: Review Protocol Compliance: 

In your chart and source document review, you can verify that subjects were sign at the right times and the right procedures were conducted as per the protocol. You will have study-specific procedures for reporting deviations. Deviations of a serious nature may be reported in an expedited manner and may need to go to the EC (dosing errors, unblinding of study treatment, subject enrolled that did not satisfy entry criteria, etc.)

5: Review Investigational Product (IP):

The study protocol will explain how the IP is to be stored, dispensed, and returned. Verify that all of this occurred properly by reviewing temperature logs, storage facilities, administration records, IVRS entries/reports for subject-specific IP accountability, and speaking to the relevant personnel.

6: Regulatory Binder / Essential Documents Review:

Determine if any forms need to be updated or pulled for the Trial Master File (TMF). The TMF is meant to be an exact replica of all the documentation at the site.

7: Confirm Site Adequacy / Site Status:

Determine if there are new staff at the site or if staff have left. Confirm that there are adequate study supplies.

8: Study-Specific Monitoring Tasks:

Depending on the protocol, you may need to perform additional tasks such as shipping materials back to headquarters (for example lab specimens, xrays, etc.), calibrating or reviewing calibrations of equipment, site training, etc.

9: Review Ongoing or Pending Issues from Previous Visits:

At some point during every visit work with the staff to resolve any items identified at previous visits as ongoing issues. Indicate in your report once these are resolved.

10: Review of findings with the site:

Whether or not you find issues during your visit, keep the site staff posted on your progress and how things are going. Especially, if the Principal Investigator is not available during the visit, be sure to summarize everything accurately and completely in your follow-up letter.