Welcome and Introduction

In 2016, MCC conducted an industry survey that examined organizational approaches and e-data sources driving centralized monitoring programs. With the adoption of ICH E6 (R2), MCC is conducting a new survey in order to assess how Centralized Monitoring is being implemented across organizations. MCC is soliciting your feedback about how responsibilities are distributed, the impact on study plans, approaches to KRIs and other methods of assessing data, and whether you have experience with regulatory inspections of studies using Centralized Monitoring.

The survey should take approximately 10 minutes to complete. Your individual survey responses will be kept confidential. A summary of the results will be available to those who complete the survey and provide their contact details.  

Using the Survey Technology:
*   You are able to review your responses and comments on any previous page by using the "Prev" button.  Do not use you browser's back button.

*   You may leave the survey and return to complete it later.
    There is no "save" button.  To save your work, complete the current page and go forward one page (“Next”). 
    You may now close survey.  
    To return to your saved survey, you must use the same computer.

Please forward this survey to any colleagues who are responsible for the areas described in the survey.
Thank you for sharing your time and knowledge.

Linda Sullivan
1-317-622-0266 ext 102

Company Information

* 1. Please select the option that best describes your organization.

* 2. What is the size of your organization?

* 3. Which of the following clinical trial/study phases is your organization involved with? Select all that apply.

* 4. Your role

* 5. Does your organization conduct (or plan to conduct) formal assessments of project/protocol-level risk prior to study conduct?

* 6. Does your organization repeat (or plan to repeat) the assessment of project/protocol-level risk during study conduct?

11% of survey complete.