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ACDM RBQM Questionnaire

ACDM RBQM Questionnaire

The purpose of this questionnaire is to survey the ACDM community to understand which types of risk-based quality management practices have been implemented on clinical trials to date.

  • The target audience for this questionnaire are sponsor and CRO organisations with individuals directly connected in the day-to-day running of clinical trials. ACDM members representing other types of organisations such as technology providers need not respond. 
  • No personal information is collected as part of the survey. It is anticipated the questionnaire takes no longer than 5 minutes to complete. 
  • The aim of the questionnaire is primarily to assess adoption and familiarity with RBQM concepts. 

Thank you for your time. All responses will be immensely valuable and help us formulate further research into RBQM adoption moving forward.

ACDM RBQM Survey
What category best describes the organisation you represent ?
What functional group do you belong to ?
What level best describes your role within your organisation ?
Has your organisation implemented a proactive Risk Assessment on at least one clinical trial ?
If there is anything additional you would like to share regarding your adoption of a Risk Assessment process then please feel free to add here
Has your organisation implemented Quality Tolerance Limits on at least one clinical trial ?
A Quality Tolerance Limit is defined as a metric measured at the study-level, with tolerance thresholds set to indicate if the trial is at significant risk.
If there is anything additional you would like to share regarding your adoption of Quality Tolerance Limits then please feel free to add here
Has your organisation implemented Key Risk Indicators on at least one clinical trial ?
If there is anything additional you would like to share regarding your adoption of Key Risk Indicators then please feel free to add here
Has your organisation implemented the definition of Critical To Quality Factors (CtQs) and critical data to operate differently with respect to monitoring and data management ?
For this question you can select all that apply
If there is anything additional you would like to share regarding your adoption of Key Critical To Quality Factors (CtQs) and critical data then please feel free to add here
Has your organisation implemented reduced levels of Source Data Verification (SDV) on at least one clinical trial ?
If there is anything additional you would like to share regarding your adoption of Source Data Verification then please feel free to add here
Has your organisation implemented reduced levels of Source Data Review (SDR) on at least one clinical trial ?
If there is anything additional you would like to share regarding your adoption of Source Data Review then please feel free to add here
Has your organisation implemented reduced frequency of On-Site Monitoring on at least one clinical trial ?
If there is anything additional you would like to share regarding your management of On-Site Monitoring then please feel free to add here
Has your organisation implemented Remote Monitoring on at least one clinical trial ?
If there is anything additional you would like to share regarding your management of Remote Monitoring then please feel free to add here
Finally, has your organisation adjusted Data Management processes to implement risk based approaches, on at least one clinical trial, for the following?
For this question you can select all that apply
If there is anything additional you would like to share regarding your adjustment of Data Management processes then please feel free to add here