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Monitoring

ICH GCP defines monitoring as “the act of overseeing a clinical trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Good Clinical practice, SOPs and relevant regulatory requirements”

 The GG&C monitors purpose is to ensure and verify 

  • The rights and well-being of human subjects are protected
  • The reported trial data are accurate, complete, and verifiable from source documents
  • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

 

The clinical trial monitors (CTMs) are sponsor representatives who review and update monitoring procedures, attend trial specific meetings, ensure compliance and consistency to regulatory and local procedures, and review protocol deviations. CTMs are appropriately trained and have the knowledge to escalate protocol deviations and identify serious breaches of GCP.  The CTMs assist with risk assessments and implement a trial specific monitoring risk assessment. The specific monitoring risk assessment aids the monitoring plan development.   CTMs ensure patient safety on trials is upheld, reviewing SAEs and identifying unreported SAEs and in the identification and analysis of repeated trends within trials.

 

Our team is made up of highly experienced individuals with varying backgrounds from nursing, science undergraduates and post graduates in addition to NHS and commercial backgrounds.

 

Due to the continually evolving nature of clinical trials and the recent global COVID-19 pandemic, new processes had to be rapidly developed and put in place to ensure ongoing oversight for new and existing clinical trials within our portfolio.  Remote and central monitoring processes were utilised whilst minimising the burden on site staff as far as possible.  All monitoring plans were reviewed to ensure compliance and addendums added to document any changes that were required.

The types of visit we conduct – Site Compliance, Routine monitoring, Close Out and For Cause visits.

 

Roles and Responsibilities

Ensure the safety, rights and well-being of trial subjects are protected

Data Integrity

Consent

Protocol Compliance

GCP Compliance

Safety

Delegation of Duties

Training

IMP Management

Documentation

Approvals

Facilities and Equipment

 

CTMs generate a visit report using the Q-Pulse database to manage actions raised during visits and ensure any non-compliances are rectified and recorded appropriately.

 

Services and Support Provided

  • Monitoring of Sponsor / host-sponsored CTIMPs, High-risk non-CTIMPs, and device trials
  • Non-commercial and commercial monitoring
  • Building a relationship between sites and sponsor
  • Identification of trends within a study (e.g. lab results being missed, deviations, issues with the study, site staff etc.)
  • Input into risk assessment
  • Identification of serious breaches
  • Feedback regarding site and non-compliance issues
  • Site training – protocol, eCRF completion

 

When to Get Us Involved

  • Grant application – Costings
  • During the start-up /set-up – Budgets/funding, logistics of the source data, feasibility
  • Risk assessment – Early input for development of the monitoring plan
  • During the study – Amendments, safety issues, database issues, etc.
  • End of study – Close-out activities

 

What monitoring is?

What monitoring isn’t?

Collection and analysis of information to track progress in a clinical trial.

 

Evaluation of any type including process evaluation

Critical to ensure the safety, rights and wellbeing of trial patients are upheld.

Audits and inspections

Risk assessment defines level of monitoring based on objective, purpose, design, complexity, blinding, size and endpoints of the trial and is an ongoing process defined by amendments, site problems or other assessments.

It does not usually occur just once. (unless a company has approached the monitors for a one time visit, which is agreed at the start)

Ongoing occurrence throughout the clinical trial determined by the risk assessment and monitoring plan.

Quality Assurance

Helps in order to identify trends and patterns in data, report deviations and non-compliances

 

Last Updated: 17 December 2021