eTMF Survey 2021 V1

Your Organisation
eTMF Experience
Select Role
CRO/Sponsor Role
Site Role
eTMF SP Role
Other Role
All Roles
eTMF Needs
eTMF Future
Thank You

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Electronic Trial Master File (eTMF) Survey
State-of-the-Art and Future Trends
WELCOME

The goal of this survey is to develop an understanding of the state-of-the-art and future trends for Electronic Trial Master Files (eTMFs).

We are asking you to complete a series of questions on current experience with eTMF and your expectations for the future. There are approximately 20 questions, depending on the role(s) your organisation fulfils within a Clinical Trial.

We will use an anonymous summary of the information you provide to facilitate discussion during our Autumn 2021 meeting on 21 October 2021. The anonymous summary of results will be available for download by eCF members after the meeting.

The survey will close on October 15, 2021.

Thank you for your help!

Definitions Used Within the Survey

Essential Document refers to documents and data which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

Electronic Trial Master File (eTMF) refers to the collection of essential documents retained by the sponsor, site, vendor, CRO and other partners in a Clinical Trial within an electronic system. It therefore comprises the Sponsor eTMF, the site eTMF (also referred to as the Investigational Site File or ISF), the vendor eTMF and the CRO eTMF.

Your Organisation
1. Organisation (select from dropdown list)
Your organisation will not appear in any summary
2. Not in the list of Organisations?... please provide your organisation name
If your organisation is not a member, you can still participate in the survey
3. Please select one of the following options that best describes WHERE YOU ARE TODAY with eTMF solutions for managing essential documents for a Clinical Trial

No experience
Some experience - piloting
Some experience - using in trial(s)
Experienced - completed trial(s)
Very experienced - it is a way of life!

B. Specific Questions About Your Role(s) in a Clinical Trial
You have said that you have experience with eTMF.

We would like to ask you questions about your experience and your future needs...

B. Specific questions about your role(s) in a Clinical Trial (6-9 questions per relevant role)

C. General questions for all roles (9 questions)

D. Your needs for improvement (1 question)

E. Your vision for the future (3 questions)
4. Select a role that your organisation represents in a Clinical Trial. You will be asked a series of questions on your organisation's experience with eTMF in the role.
You can revisit this question for further roles. Select 'I have completed all relevant roles' when you are ready to move to general questions
Role Definitions...
- Clinical Trial Sponsor (Sponsor)
  An individual, institution, company or organization (for example, a pharmaceutical company or a research organisation) that takes the responsibility to initiate, manage or finance the clinical trial
- Clinical Trial Site (Site)
  An institution (for example, a hospital) responsible for providing the team of individuals for the conduct of the clinical trial
- Contract Research Organisation (CRO)
  A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions
- eTMF Solution Provider (eTMF SP)
  An organisation providing the validated eTMF solution for used by the sponsor, site, CRO or other partner in a Clinical Trial
- Other Service Provider (OSP)
  A third party in a clinical trial that is storing essential documents/data that will be required for the trial (for example, CSV records, EDC data)
Save & Resume Later

Blank	Percentage
A sponsor provided eTMF solution
Your own eTMF solution

Blank	Percentage
Have a commercial sponsor (e.g. Pharmaceutical company)
Don't have a commercial sponsor (e.g. government or institution)

QUESTIONS FOR OTHER ROLE
Other Service Provider Role...
A third party in a clinical trial that is storing essential documents/data that will be required for the trial (for example, CSV records, EDC data)
29. What OTHER role within a Clinical Trial is represented by your organisation?
30. What essential documents/data for a Clinical Trial are you responsible for?

31. Do you use an electronic solution for storing and managing these essential documents/data?

No, we don't use an electronic system

Yes, we use an internally developed system

Yes, we use a commercially available system

Yes, we use a system selected for the trial by the Clinical Trial sponsor /CRO

Others

32. Do you want to select another role?

Yes, let me select another role
No, I have completed relevant roles
Save & Resume Later

Blank	Specify
Other 1
Other 2
Other 3

Use Text Editor to add content
The Future of eTMF in your Organisation

44. Please select one of the following options that best describes WHERE YOU WANT TO BE in the next 2-3 years with eTMF solutions for managing essential documents for a Clinical Trial

No experience and no plans to start

No experience but plans to explore

No experience but plans to implement

Some experience - piloting

Some experience - using in trial(s)

Experienced - completed trial(s)

Very experienced - it will be a way of life!

45. What is your vision for the future of eTMF?
46. What do you consider to be the key challenges in realising this vision?
47. General Comments (Please provide any additional information from your understanding or experience with eTMF)
Save & Resume Later

THANK YOU
Thank you for participating in the survey. The findings will be summarised and presented during our virtual workshop on 21st October. An anonymous summary of the findings will be available for download from the Members Area of the website after the workshop. When you click on SUBMIT your responses will be saved and EMailed to you (if you provide an EMail address)
Email
This will only be used to send you a copy of your survey responses

Blank	Never	During the Trial	Immediately the trial finishes	After approval of the medicinal product	After the mandatory retention period	When space is needed	I don't know
When do you lock INDIVIDUAL essential documents of a trial?
When do you lock/freeze the ENTIRE Trial?
When do you transfer a trial’s locked/frozen eTMF into LONG TERM STORAGE?

Blank	Not Available	Not Satisfied	Somewhat Satisfied	Neutral	Satisfied	Very Satisfied
Electronic filing cabinet
Repository of templates
Automation of tasks
Role-based dashboards
Risk management features
Collaboration features
Centralised messaging and Email
Automated synchronisation with partner eTMFs
Event notifications
Integration with other site systems
Import/export features
Locking of records
Archive generation for long term storage
Compliance with Reference Models
Compliance with Regulatory Guidelines e.g. Audit Trail
Data security to segregate information and control access rights
Advanced search
Reporting
Other 1
Other 2
Other 3

Electronic Trial Master File (eTMF) Survey

Your Organisation

B. Specific Questions About Your Role(s) in a Clinical Trial

CRO AND SPONSOR QUESTIONS

Your Role as a CRO...

Your Role as a Clinical Trial Sponsor...

Your eTMF Solution(s)

Interaction with Clinical Trial Sites

SITE QUESTIONS

Your Role as a Clinical Trial Site...

Your eTMF Solution(s)

eTMF SP QUESTIONS

Your Role as an eTMF Solution Provider...

About Your Offering

QUESTIONS FOR OTHER ROLE

Other Service Provider Role...

QUESTIONS FOR ALL ROLES WITH eTMF EXPERIENCE

C. Questions for All Roles with eTMF Experience

Management of Your eTMF

Regulatory Inspection of your eTMF Solution / Process

Your Needs and Expectations for eTMF

The Future of eTMF in your Organisation

THANK YOU