MHRA TMF Focus Day Question Title * 1. Organization type Sponsor CRO eTMF/System Vendor Consultant Site Health Authority Other Other (please specify) OK Question Title * 2. Rank MHRA TMF Focus Day topics in your order of criticality 1 2 3 4 5 6 7 8 Email 1 2 3 4 5 6 7 8 Gap in senior management focus 1 2 3 4 5 6 7 8 Challenges with health authority guidance and reflections 1 2 3 4 5 6 7 8 Gap in inter-department participation 1 2 3 4 5 6 7 8 Gap in organizational awareness 1 2 3 4 5 6 7 8 TMF Oversight 1 2 3 4 5 6 7 8 Dealing with M&A 1 2 3 4 5 6 7 8 Dealing with multiple organizations / parties OK Question Title * 3. Rank your current TMF problems in order of criticality 1 2 3 4 5 6 7 8 9 N/A Multiple Systems N/A 1 2 3 4 5 6 7 8 9 N/A Multiple Structures N/A 1 2 3 4 5 6 7 8 9 N/A Document Quality N/A 1 2 3 4 5 6 7 8 9 N/A Completeness N/A 1 2 3 4 5 6 7 8 9 N/A Timeliness N/A 1 2 3 4 5 6 7 8 9 N/A Scramble for inspection N/A 1 2 3 4 5 6 7 8 9 N/A Long term Archive N/A 1 2 3 4 5 6 7 8 9 N/A Conflicting Processes N/A 1 2 3 4 5 6 7 8 9 N/A Other N/A OK Question Title * 4. Rate your next generation eTMF interest in order of criticality 1 2 3 4 5 6 Not interested eTMF Metrics Not interested 1 2 3 4 5 6 Not interested Other Not interested 1 2 3 4 5 6 Not interested Paper-free eTMF Not interested 1 2 3 4 5 6 Not interested Subartifacts Not interested 1 2 3 4 5 6 Not interested eISF Not interested 1 2 3 4 5 6 Not interested eClinical integrations Not interested OK Question Title * 5. ASK THE MHRA ANYTHING: Questions are being collected at feedback@tmfrefmodel.com or can be asked below. Please use as much detail as possible. Your query will be anonymized –contact information is only requested to ensure that we have any clarification needed to accurate represent your question or to group it with similar queries. OK Question Title * 6. Your Contact Information: if you have added a question or are interested in survey results, please provide your name and email below. All results and questions for the MHRA will be anonymized. OK DONE