What is a monitoring plan clinical research?
The monitoring plan is the document that details the monitoring policies and procedures, and the proposed frequency of on-site monitoring visits across the trial sites, for a particular trial. Procedures, which includes site feasibility and initiation, schedule for on-site monitoring visits and site close-out.
How do you write a clinical trials monitoring plan?
The trial monitoring plan document should:
- Be developed a systematic, prioritized, risk-based approach and emphasize the monitoring of critical data and processes.
- Identify the visit schedule and describe the types of visits to be conducted i.e. interim monitoring visits, for-cause visits and close out visits.
What should a study monitoring plan contain?
The plan should describe what adverse events will be tracked, how this will be accomplished and how they will be reported. This includes who has the responsibility for reporting, and the roles and responsibilities of each person on the clinical study team who is involved in safety reporting.
What is a monitoring plan?
A monitoring plan is a written plan that describes what will be monitored and how. A good monitoring plan is simple. It is based on existing monitoring mechanisms and sources of information, and collects only as much information as is used by the project team.
How do I prepare for a monitoring visit?
Preparing for a periodic monitoring visit:
- Identify a quiet place for the monitor to work and ensure access to a copy machine, phone, water fountain, and restroom.
- Complete all necessary CRFs.
- Confirm that Serious Adverse Event (SAE) forms have been submitted and are available for review.
What is the purpose of GCP?
Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects.
How do you write a clinical monitoring report?
5 guidelines for writing a useful clinical monitoring report
- Do Your Homework Before the Site Visit.
- Take Good Notes During the Visit.
- Write the Report as Soon as Possible.
- Check Reports Carefully.
- Be Sure the Report Only Includes Essential Information.
- Bonus: Take the Report from Good to GREAT.
What is a safety monitoring plan?
Definitions. Data Safety Monitoring Plan (DSMP): A DSMP is a quality assurance plan for a research study. A Data and Safety Monitoring Plan (DSMP) is meant to assure that each clinical investigation has a system for appropriate oversight and monitoring of the conduct of the clinical investigation.
What should be included in the monitoring plan developed by the sponsor?
The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes.
How do I make a monitoring plan?
Steps
- Step 1: Identify Program Goals and Objectives.
- Step 2: Define Indicators.
- Step 3: Define Data Collection Methods and TImeline.
- Step 4: Identify M&E Roles and Responsibilities.
- Step 5: Create an Analysis Plan and Reporting Templates.
- Step 6: Plan for Dissemination and Donor Reporting.
What is the clinical monitoring plan (CMP)?
The Clinical Monitoring Plan (CMP) establishes the guidelines for conducting clinical site monitoring activities for National Institute of Mental Health (NIMH) Protocol < protocol number, protocol title>.
Who is responsible for preparing a clinical monitoring plan?
Clinical Research Associates (CRAs) or Principal Investigators (PI) responsible for preparing a Clinical Monitoring Plan How to Use This Template This template contains two types of text: instruction/explanatory and example text.
What is included in this template for a clinical monitoring plan?
This template includes a proposed structure for a Clinical Monitoring Plan as well as draft language and other guidance. Best Practice Recommendations Review this draft template and customize to the specific needs and requirements of the monitoring group.
What is included in the draft template for a monitoring plan?
This template includes a proposed structure for a Clinical Monitoring Plan as well as draft language and other guidance. Best Practice Recommendations Review this draft template and customize to the specific needs and requirements of the monitoring group. Sample text may be updated as needed.