econsent Landscape Assessment: 2016

Transcription

1 e Landscape Assessment: 2016

2 e Landscape Assessment: Overview The intention of the e Landscape Assessment is to share the collected, aggregated, and blinded survey data on global experience with e. The survey was sent to pharmaceutical companies, clinical research organizations (CROs), and e vendors in December We advise users to be cautious in their interpretation and use of the data. Consider the following: Due to the anonymized approach for data aggregation, there could potentially be duplicate data from the same submission/pilot. For example, a pharmaceutical company and e vendor could report on the same submission. A lack of precedent of an operational or multi-media component in a given country does not imply that it CANNOT be used. For example, the lack of use of electronic signature in a given country may be due to business decisions, rather than due to regulatory considerations. The information provided does not supersede any local regulation. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 2

3 e Landscape Assessment: Data Presentation The Data is presented in 3 levels: 1. Global Level Global view which shows where survey respondents have submitted e and used e to consent patients. Note: Additional data included for the use of e with vulnerable populations and reasons for removal of a country from planned e strategy. 2. Country Level Country-specific information which highlights the multi-media components, operational considerations, signature types, and and IRB submission materials used. Details on and IRB feedback are also included. 3. Detailed Level The blinded and aggregated results from the survey are provided in detail in an excel sheet. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 3

4 e Landscape Assessment: Stakeholder Response Breakdown There were a total of 17 responses to the 2016 e Landscape Survey Sponsor Company 3 e Vendor 2 CRO Stakeholder Perspective 1 Note: 1 response was submitted by a self-identified patient. The response answers are not included in the summary report or detailed report. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 4

5 Global Level

6 e submissions e Around the World 2016 consent patients The following data were collected in December 2016 from 16 responses to the TransCelerate e Landscape survey. In total, according to the survey results, 29 countries have had e submissions (to s and/or s), of which 12 actively consented patients using e. Originally there were 17 responses. 1 response was submitted by a self-identified patient and is not included in the summary report or detailed report. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 6

7 2016 Global e Submissions and s ed The following data were collected in December 2016 from 16 responses to the TransCelerate e Landscape survey. Countries with e submissions: 29 Countries where s were consented via e: 12 Country e Submissions s consented w/ e Country e Submissions s consented w/ e Argentina Japan Australia Korea Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway China Poland Finland Romania France Saudi Arabia Germany Spain Greece Taiwan Hungary Turkey India UK Israel Italy USA 1 response was submitted by a self-identified patient. The responses are not included in the summary report or detailed report. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 7

8 Reasons for Removal of Country from e Strategy In total, 5 responses out of 16 were received for reasons that a country was removed from the original scope of an e pilot 2 Total Responses 3 Health Authority/ IRB Feedback Additional information provided USA: One IRB did refuse e as the site were already piloting for another sponsor. Some countries will not allow e to be utilized at all. We tried in Japan. In Japan would do esource but the PIs wanted to use paper ICFs at the last minute. did not accept e Resistance to acceptance of esignature, or lack of commitment to accept esignature Note: In this survey, we did not collect information regarding which countries were specifically removed. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 8

9 Vulnerable Populations Included in e Study In total, 4 responses out of 16 were received for respondents who included vulnerable populations in their study. Their free response details are included below. Vulnerable population is defined as a subset of the community that may have additional considerations impacting their ability to make a voluntary and informed decision (e.g., children, physically/visually impaired) 4 Free Text Responses Deployed for pediatric and rare disease populations, no special considerations other than to reframe some of the pediatric content to be age appropriate for educational purposes. Illiterate patients in India One of the pilot studies included a population with visual impairment. For this population, we included a zoom in/zoom out feature to enlarge the font size, we also provided sites with large monitors so the patients could view the eicf more easily; this may be a consideration for use of eicf in other visually impaired populations. One of the studies was in a population of rheumatoid arthritis patients, we provided a stylus as an option to interact with the ipad Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 9

10 Country Specific Level

11 How to Use the Country-Specific Information Multi-Media : The multi-media components included in the total submission documents and/or used to consent patients in this country will be highlighted in green, those not indicated in the survey responses will be greyed out. s/ : The operational considerations and issues included in the total submission documents and/or used to consent patients in this country will be highlighted in blue, those not indicated in the survey responses will be greyed out. Country & Flag The asterisk designates fields that have additional data in the Excel spreadsheet containing the blinded and aggregated survey results. Response Breakdown: Of the 16 total survey responders, the number that submitted for e and consented patients using e in this country. Signature Types: Check marks will indicate the signature types used for sites and patients from this country. Submission Documents: Check marks will indicate the type of document submitted to s and for this country. Feedback : Any free text responses captured via the survey for feedback received from, s, and other official reviewers for submission documents to this country. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 11

12 Description of Multi-media Media Type Tiered Video Audio s Callout es Flags Section-based Description form that front loads all essential elements into a concise opening section, and assigns more-detailed, information to later sections Visual and auditory overview of information included in the ICF Auditory overview of information included in the ICF Visual that help to explain and reinforce key trial components or complex topics Used to highlight and reinforce key ideas in 1 or 2 simple sentences within the consent content section Highlights key information/ concepts Provides definitions for unfamiliar words and phrases Mark or flag content or specific words/sentences where a study participant would like to ask a question to ensure his/her clarity and comprehension, or to simply indicate that a question exists regarding the specific text Per section confirmation of patient understanding Highlight areas and add notes where the patient has questions or concerns Free text fields to record all documentation regarding the informed consent process Additional details can be found in detailed view. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 12

13 Description of s/ /Issue Type received paper copy after consenting received electronic copy after consenting - (- Date/Time s On- Description the patient consents using e, the paper copy is provided to the patient. the patient consents using e, an electronic version is provided to the patient. Multi-media components (e.g.,video, audio) from the e are available on the patient s own device outside of the site. The name of the patient is a captured field for the e form. e is delivered on site-owned device e is delivered on patient owned device process conducted outside of site. Additional details can be found in detailed view. Date and time stamp captured at the start of consent, for each section of the consent, and/or completion of the consent form. choice selected in survey. Additional details can be found in detailed view. Additional consideration was taken while importing or planning to import devices into the specific country on the trial and the consent process is done remotely. on the trial and the consent process is completed on site. on the trial and consent process is completed at a centralized location. form of monitoring the trial and consent process. Additional details can be found in detailed view. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 13

14 Argentina 2 Total Responses 2 e Submissions 0 s / Flag es Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 14

15 Australia 2 Total Responses 2 e Submissions 0 s / Flag es Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 15

16 Austria / Flag es 1 Total Responses 1 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 16

17 Belgium / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 17

18 Brazil / Flag es 2 Total Responses 2 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 18

19 Canada / Flag es 4 Total Responses 4 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- On- - s PDF/Word Feedback Due to study design, Health Canada will only be involved in the second phase and wants to receive a report on the first phase before they grant approval Submissions occurred, but approval will only be given after the Health Canada "No Objection letter"" is received N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 19

20 China / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 20

21 Finland / Flag es 1 Total Responses 1 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- No feedback N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 21

22 France / Flag es 4 Total Responses 4 e Submissions 3 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 22

23 Germany / Flag es 2 Total Responses 2 e Submissions 2 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- On- - s PDF/Word Feedback No feedback N/A Requested to make it clear in the information and IC that in any case for study participation the written IC including the hand-written date are decisive Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 23

24 Greece / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 24

25 Hungary / Flag es 2 Total Responses 2 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 25

26 India / Flag es 2 Total Responses 2 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- On- - s PDF/Word Feedback Requested changes to video and audio content (additional specific language added to video voiceover) Expressed interest in expanded multimedia content Told to collect either electronic or paper signature, not both, as both would be a burden to the patient General Positive/Supportive Feedback N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 26

27 Israel / Flag es 1 Total Responses 1 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 27

28 Italy / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 28

29 Japan / Flag es 2 Total Responses 2 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback Feedback regarding site On- No feedback N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 29

30 Korea / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 30

31 Mexico / Flag es 2 Total Responses 2 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 31

32 Netherlands / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 32

33 New Zealand / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 33

34 Norway / Flag es 1 Total Responses 1 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved Additional required document review by data privacy committee Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 34

35 Poland / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 35

36 Romania / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 36

37 Saudi Arabia / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 37

38 Spain / Flag es 2 Total Responses 2 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission was approved On- No feedback and submission was approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 38

39 Taiwan / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 39

40 Turkey / Flag es 1 Total Responses 1 e Submissions 0 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted PDF/Word (- - s Feedback N/A On- N/A N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 40

41 United Kingdom / Flag es 3 Total Responses 3 e Submissions 1 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- On- - s PDF/Word Feedback No feedback and submission approved No feedback and submission approved The Vendor had met with the HRA in the UK and had discussed the use of their e system and had secured their approval Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 41

42 United States / Flag es 14 Total Responses 14 e Submissions 14 s Signature Types Signature Advanced Signature On Paper Facing Screen Shots s/ Submitted (- - s PDF/Word Feedback No feedback and submission approved On- No feedback and submission approved N/A Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 42

43 Detailed information Link to detailed aggregated information from the survey Link to the survey questions Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 43