The type of monitoring entity or plan can widely differ among studies. However, all clinical trials must be monitored at least by the assigned Medical Monitor. Additionally, it may require further monitoring by an independent safety monitor.
This is an MS Word template to use as a starting point for preparing a Medical Monitoring Plan for either clinical trials or clinical research. Also, we have included a proposed structure for a medical monitoring plan and draft language and other guidance to assist you in creating a medical monitoring plan.
Moreover, we have saved this template in different formats (.docx, .dotm, .dotx, .docm, .doc, and .dot) to make sure it is compatible with all systems.
Please note that in this template:
- The yellow-highlighted text enclosed with < > indicates a placeholder where specific detail is inserted (replace as appropriate).
- Ensure that you replace all placeholders and example text with study-specific information.
- In the template, the instructions and explanatory text are indicated by [blue italics], which is used for explanations only and must not be included in the final document.
- Please review this template and feel free to adapt it to the specific needs and requirements of the monitoring group and study.
- You should use the logo of the Institution on this form.
- Leave the template version information in the lower left-hand corner of the documents.
Using this template and the instructions provided in it:
- Helps you follow the ICH guidelines to prepare a compliant Medical Monitoring Plan that addresses the study requirements.
- Assists the Medical Monitors to include the required items (roles/responsibilities within the trial, cooperation with the Sponsor and other project team members) in this document.
Who Can Benefit From This Course
The template is intended to assist the following in the process of creating a medical monitoring plan for the clinical trials:
- Medical monitors
- Clinical research associates
- Project manager
- Sponsor’s Project Team
- ID: 950
- SKU: TE-0001-RC
- Type: Template
- Format: Template File (.docx, .dotm, .dotx, .docm, .doc, and .dot)
- Date of Last Update: Jan 20, 2017
- Price: $100.00
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