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Survey: How Have the Regulations Influenced Risk Based TMF Strategies?

Sarah Hitching (Hedian Records Management and HSRAA Member) will be presenting at the 2024 CDISC + TMF Interchange in Berlin (24th – 25th April 2024) on the subject of ‘How Have the Regulations Influenced Risk Based TMF Strategies?’

You can look up more about Sarah’s presentation under ‘Program’ on the 2024 CDISC + TMF Europe Interchange | CDISC website here.

As part of the presentation, Sarah plans to present the current status of TMF risk based strategies used currently by companies and this is where she needs your help. Sarah is interested to know if your company has instigated any TMF risk based strategies and if so was there a regulation or guidance that influenced it e.g. EMA Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) EMA/INS/GCP/856758/2018. We would really appreciate just 10 minutes of your time to answer the questions anonymously. Sarah will present the resultant findings during her presentation at the 2024 CDISC + TMF Interchange.

Sarah is happy to share the summary results of this survey with you after the presentation has taken place. All you need to do is provide your email address in the box provided in the survey (question 18).

The survey is made up of four short sections and all questions in a section need to be answered before moving to the next section. In all there are 18 questions. If you are willing to take part in the survey, please click on the link below.


If you have any questions or issues with the survey, please contact Sarah at