1. User Survey Responses: EDM Reference Model for Regulatory Submissions Antoinette Azevedo e-SubmissionsSolutions.com Core Team Member User Survey Co-Designer

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3. Survey designed by working group members 17 questions in 3 categories –Survey Responder Background –Use of the Reference Model –Communications about the Regulatory Submissions Reference Model Developed in SurveyMonkey.com Methodology Drug Information Associationwww.diahome.org3

4. SurveyMonkey.com link 16 November 2011 – 15 December 2011 DIA SIACs –Document and Records Management –Electronic Regulatory Submissions –Medical Writing LinkedIn Groups for EDM Reference Model –Regulatory Submissions –TMF Distribution Drug Information Associationwww.diahome.org4

5. Determine how to meet the needs of the user community interested in learning about and implementing the EDM Reference Model Objective Drug Information Associationwww.diahome.org5

6. Responses to Survey Drug Information Associationwww.diahome.org6 Total = 94

7. Click to edit Master title style SURVEY RESPONDER BACKGROUND Drug Information Associationwww.diahome.org7

8. 1. My role is Drug Information Associationwww.diahome.org8 Answered question 92 Skipped question 2 Other: Senior Business Analyst Pharma and Devices Federal IT Contractor Academic Research

9. 2. My company size is (US$ annual revenue) Drug Information Associationwww.diahome.org9 40 responders did not supply company revenue

10. 2. My company size is (US$ annual revenue) Drug Information Associationwww.diahome.org10

11. 2. My company size is (US$ annual revenue) Drug Information Associationwww.diahome.org11

12. 3. My company headquarters is: Drug Information Associationwww.diahome.org12 Answered question 89 Skipped question 5 Other: 2 – India 2 – Switzerland 1 – Israel

13. 4. My location is Drug Information Associationwww.diahome.org13 Answered question 88 Skipped question 6 Other: 3 – India 2 – Switzerland 1 – Argentina

14. Click to edit Master title style YOUR OPINIONS ABOUT THE REGULATORY SUBMISSIONS REFERENCE MODEL Drug Information Associationwww.diahome.org14

15. 5. How did you hear about the Reference Model? Drug Information Associationwww.diahome.org15 Answered question 83 Skipped question 11 Other: 3 - Members of working group 1 – LinkedIn eCTD group 1 – Pharma company exec 1 – Reg op colleagues 1 – eXL Pharma conference

16. 5. What is your impression of the Reference Model Drug Information Associationwww.diahome.org16 Answered question 77 Skipped question 17 10 Other text responses

17. I've not seen/heard about it in detail for about 3 yrs...so don't know what it looks like now--it was great last time I saw it! (I was at an EDM ref model meeting in Horsham) It seems to be too focused on the submission output and not focused nor organized to meet the expectations of the contributing functions. For example, all Regulatory team members will understand the CTD structure and therefore the organization of the reference model, but not all clinical team members think in terms of a clinical study report as the final output and therefore have slow adoption with the model in the current state. All clinical team members, however, really seem to "get" the TMF model as it is mirrors the way they work. It isn't as simple as a vendor putting the model into a COTS solution, the vendors implementation needs to make sense for all users of the system in order to get the content contributors to use the system. Why have users apply metadata to documents over and over when the eCTD tools only need it once? Not a good use of resources, time or budget. The whole idea is good, but the exectution of it includes too many fields for users (they will not be accepting) of data that means nothing to them Question 6 write-in responses Drug Information Associationwww.diahome.org17

18. needs to come with a conceptial data model as well as with an ER model, needs to be alligned with other industry terminology standards like CDISC / BRIDG, IDMP etc. Procedure and training for using the eTMF system and database No idea, got invitation - I assume - as SIAC member for the TMF reference model OPDP, Prescribing Promotion needs to be pushed as well as additional areas & metadata. not sure.. however, i think that an enhancement in the submission lifecycle -- with a focus to submission output is always good. 1) enhance with artifacts from CA, AU, CH 2) Missing some artifacts required by STF 3) A few artifacts don't make sense 4) remove those not tracing to any regualtory requirement Question 6 write-in responses Drug Information Associationwww.diahome.org18

19. 7. How do you use the Reference Model? Drug Information Associationwww.diahome.org19 Answered question 63 Skipped question 31 3 Other text responses

20. New to the model - not used yet but see potential for all of the above choices Comparing with our proprietary taxonomy Currently working on getting my organization to buy into this model Question 7 write-in responses Drug Information Associationwww.diahome.org20

21. 8. How were you able to use on your EDMS project? Drug Information Associationwww.diahome.org21 Answered question 36 Skipped question 58 Could not use due to:22 responses

22. Old bespoke model in place that is being evaluated for replacement4 not knowing it was available2 Reduced the complexity for smaller companies users will not accept this much entry for every document (even archives only) The majority of my clients are not interested. They have other short term priorities such as their submissions. unaware of it. EDMS already in place. System overhaul expected within the next 18 months, expect to use the model Role as a consultant. I have to use what my client is using NA2 Would have implemented with an EDMS upgrade but we were bought by another company and this project was abandoned. Question 8 write-in responses Drug Information Association www.diahome.org22

23. very poor documentation No submission yet Too difficult to implement in the current edms Needed a more 3 dimentional model (docand attributes necessary for automation) I had DMS projects with existing systems (data migration etc). Therefore, the metadata as such were not discussed Not applicable at this time for my work (currently using only TMF Reference Model) Question 8 write-in responses Drug Information Association www.diahome.org23

24. 9. How EDMS project impacted by Reference Model? Drug Information Associationwww.diahome.org24 Answered question 54 Skipped question 40 Other: 3 – N/A 3 - Unsure

25. 4 – Not applicable/not using 3 – Difficult to measure/to be determined/unknown 1 – adds to implementation time 1 – reduce workshop time 1 – 10% 1 – 33% 1 – 40% 1 – 2 months 10. How much time reduced time of implementation? Drug Information Associationwww.diahome.org25 Answered question 13 Skipped question 81

26. 1 – 10% 1 – 25% 1 – 33% 3 - Not applicable 2 - To be determined/unknown 11. How much time reduced cost of implementation? Drug Information Associationwww.diahome.org26 Answered question 8 Skipped question 86

27. 12. Where did you retrieve your copy? Drug Information Associationwww.diahome.org27 Answered question 47 Skipped question 47 Other: 2 – N/A 1 – Didn’t know it was available 1 – Vendor 1 – and via Google

28. 13. How often check LinkedIn for news? Drug Information Associationwww.diahome.org28 Answered question 53 Skipped question 41

29. 14. How to enhance distribution of information and technical support about Reference Model? Drug Information Associationwww.diahome.org29 Answered question 52 Skipped question 42 6 responses

30. need to extend to include meta data for source documents (e.g. M3) - that distinguish the narratives from source e.g. narrative for 3.2.P.8.3 from the stability report Ask people who have implemented it, did it work out or did it create a bottleneck? No idea, not my topic Expand documentation to better explain the use of the metadata in the deployment of virtual folders/document hierarchies within the DMS. This should start with the development of vendor-specific documentation to better educate vendors about ways to implement the model in their systems, to provide more accurate storage and viewing functionality to the users. See prevous coments Question 14 write-in responses Drug Information Associationwww.diahome.org30

31. 15. Awareness of TMF Reference Model Drug Information Associationwww.diahome.org31 Answered question 57 Skipped question 37

32. 16. Desire to be involved with Reference Models Drug Information Associationwww.diahome.org32 Answered question 54 Skipped question 40

33. 17. Supplied contact information Drug Information Associationwww.diahome.org33 Answered question 37 Skipped question 57

34. Most responders hear about Reference Model thru DIA –LinkedIn groups for Regulatory Submissions and TMF are important means of communication Impression –Good for industry –More vendors should support/embrace with COTS –9 responders – support losing momentum Analysis & Conclusions Drug Information Associationwww.diahome.org34

35. Uses –EDMS design, vendor selection, implementation, integration with publishing –Education –24 of 63 responders not using Use on EDMS project (61 responses) –15 used as-is –34 extended artifacts/metadata or changed taxonomy –22 could not use the reference model Analysis & Conclusions Drug Information Associationwww.diahome.org35

36. Impact on EDMS Project –54% realized positive impact from use of Reference Model –Remainder Facilitated education of users in workshops Reduced time/cost of implementation Small use in selecting publishing tool Reduction of time/cost – few number of responses Analysis & Conclusions Drug Information Associationwww.diahome.org36

37. Wider distribution of information about working group meetings Harmonize with TMF reference model Presentation of case studies thru DIA & other industry meetings & publications Initiate discussions on LinkedIn Information Distribution & Technical Support Drug Information Associationwww.diahome.org37

38. Keep informed about new releases Some volunteers 37 (57 skipped) supplied some contact information –100% supplied email addresses Involvement with Reference Models Drug Information Associationwww.diahome.org38

39. Preliminary analysis – first presentation of raw survey results Being assessed by EDM Submission working group Continue to refine analysis & develop action items Publish results back to DIA ConneX & LinkedIn Next Steps Following Survey Drug Information Associationwww.diahome.org39

40. Click to edit Master title style QUESTIONS & DISCUSSION Drug Information Associationwww.diahome.org40