CRP 106 Lecture 5

Question 1

Monitoring Plan

Answer 1

Developed by sponsor
-tailored to the specific human subject protection and data integrity risks of the trial
* Primary objectives of the monitoring plan is to delineate:
* How study will be monitored (on-site, remote, etc)
* How often visits are to occur
* Under what circumstances these visits are to occur
* What specific activities are to occur during the monitoring visit

Question 2

Frequency of Monitoring Visits

Answer 2

risk assessment
* Complexity of study protocol
* Disease being investigated
* Experience of investigators and their staff
* Number of study subjects enrolled at the site
* Rate of enrollment
* Faster enrollment will require more visits
* Slower recruiting sites might benefit from visit to provide motivation and support
* Site performance

Question 3

Monitoring plan contents

Answer 3

• Brief description of the study
• Objectives of the study
• Critical data and study procedures
• Description of monitoring methods used
• How these methods will address study risks and data integrity
• Specific activities used to fulfil these methods – links to tools, logs, templates, etc.
• Criteria used to determine timing, frequency, and extent of planned
  monitoring activities
• What events or results trigger changed in planned monitoring activities for a site
• Description of practices to be used to document all monitoring
  related activities

Question 4

Communication of Monitoring Results

Answer 4

• Format, content, timing, and archiving requirements
• Process for appropriate communication
• Routine monitoring reports to management or other critical partners (eg:CRO or data management team)
• Immediate reporting of significant monitoring issues to appropriate
  parties
• From study management and other partners (i.e. DM) to monitor

Question 5

Management of Noncompliance

Answer 5

• Process for addressing unresolved or significant issues identified by
  monitoring
• Process to ensure root cause analyses and CAPA are conducted
• Other quality management processes applicable to the clinical
  investigation i.e. SOPs for action in response to issues

Question 6

Ensuring Quality Monitoring

Answer 6

• Description of specific training to be provided to those conducting monitoring activities
• Planned audits of monitoring activities
• Planned co-monitoring of on-site visits by monitor and monitor’s supervisor

Question 7

Monitoring plan amendments

Answer 7

• Outline what events would constitute a need for a review and
  revision of the monitoring plan
• Process to be instituted to ensure timely review and institution
  of any amendments

Question 8

Monitoring Plan Review

Answer 8

• Monitoring plan should be thoroughly reviewed prior to
  implementation
• Review should occur by anyone who has involvement in the
  monitoring of the trial OR anyone involved in decision-making that
  may be required regarding observations made during a visits

Question 9

Communication Strategy with site

Answer 9

• RBM may decrease on-site visit time, but does not mean no contact
  with sites between visits
• How will this occur?
• Telephone, email, Zoom/WebEx – scheduled/unscheduled
• What frequency?
• What strategy will you employ?

Question 10

Preparing for a Monitoring
Visit: time management

Answer 10

• Outline the activities you plan on completing during the visit
  -keep track of the amount of time you require to do source data verification/review and/or CRF review for 1 pt visit,depending
  on how many subject study visits you need to review, you will have a
  rough estimate of time required
  -Some sites are more effective than others at maintaining
  records
• Some tasks can vary significantly between visits and between
  sites
• Structure you visit so you review the high level targets first.
• High level items are those that are important to maintaining
  participant safety and data integrity
• Items are commonly observed as findings during regulatory body
  inspections and are the focus in a risk-based approach
  -adequate time devoted
  to the items that exceeded the threshold

Question 11

Critical Review Items

Answer 11

• Ensuring investigator/study team is following protocol
• Appropriate records and source documentation of study related activities are maintained
• IP accountability is accurate and appropriately documented
• Informed consent is appropriately obtained and documented
  These items are generally more challenging to verify remotely, so ideally time is set
  aside during a visit

Question 12

Monitoring Supplies

Answer 12

• Create a monitoring kit that you can take with you on a visit
• Laptop
• Hotspot (if wifi is unavailable)
• Monitoring Visit Checklist/Report
• Stationary
• Bring your study file
  -blank checklists and forms or backup device

Question 13

Before Arriving at Site

Answer 13

-knowledge of GCP, regulations, Sponsor SOPs
* Knowledge of current state at site – review previous communications with
site
* Review protocol and ICF
* Review previous monitoring reports, if available
* Review any submitted follow-up letters to the site
* Create a list of uncompleted or pending tasks
* Discuss with others in your team regarding current states at site and any
major review items
* Location Awareness
* Ensure you know where you are going – scope out your route before your trip
* Have an address available and information regarding site contacts
* Have GPS or physical map