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TMF Reference Model Results of 2013 TMF Survey #3 September 2013 Fran Ross TMF Survey Sub-team
TMF Reference Model
Results of
2013 TMF Survey #3
September 2013
Fran Ross
TMF Survey Sub-team
• TMF Survey purpose: industry-wide, gather insight into quality, cost
and effectiveness drivers of TMF management, including:
– Knowledge and use of TMF Reference Model
– Changes in TMF management and processes
– Impacts of electronic TMF and e-Investigator Site File
• Data for 2013 Survey #3 was collected in April and May of 2013
– Previous surveys were conducted in 2010 and 2012
• The survey sub-team will reconvene for work on the fourth TMF
Survey in Q114. Your feedback, insight and participation are
enthusiastically welcomed.
The TMF Survey sub-team and the Trial Master File Reference Model (TMF RM) initiative is a
subgroup of the Document and Records Management SIAC of the Drug Information Association
Trial Master File (TMF) Survey Background
2013 TMF Survey #3
• Majority of respondents from life science trial sponsors (49%)
• Most responders US / Canada based (69%)
Respondents organization types and locations
2013 TMF Survey #3
49%
24%
9%
4% 9%
4% 1% SponsorCROConsultantVendorSiteOtherAgency
69%
1%
9%
21%
US/CA
LatAm
AsiaPac
EU
Total numbers of trials and % trials outsourced
2013 TMF Survey #3
16%
16%
16% 19%
33%
% Trials Outsourced to CRO
100%
76-99%
51-75%
26-50%
0-25%
15%
26%
15%
14%
21%
9%
Numbers of active trials
1 to 4
5 to 25
26 to 50
51 to 100
101 to 500
501 to 1000
• There were a record number of 225 respondents in 2013
• Respondents well distributed in trial size, and outsourcing models
TMF SOP Adherence
2013 TMF Survey #3
Does your organization have and follow a TMF/ISF SOP?
58% 22%
1% 8%
4% 7%
Yes, consistently
Yes, inconsistently
Yes, not followed
No, in development
No SOP
Not required
Paper and electronic TMF file of record
2013 TMF Survey #3
What format is your TMF file of record?
All Inspectable TMF in paper
36%
All Inspectable eTMF 13%
Combo of paper and eTMF
42%
n/a 9%
0.0%
25.0%
50.0%
75.0%
100.0%
2010 2012 2013
NA
Some studies inspected inpaper, some eTMF
Inspectable TMF in paper
Inspectable eTMF
Steady, incremental growth in eTMF
eTMF status
2013 TMF Survey #3
0%
25%
50%
75%
100%
2010 2012 2013
Unk / NA
Not considering
Actively Planning
Evaluating
Actively Building
We have an eTMF
We currently use eTMF 37%
Building / Implementing
14%
Evaluating 20%
Actively Planning 5%
Not Considering 9%
NA / Unk 15%
More than one eTMF?
2013 TMF Survey #3
15%
14%
67%
4%
We have multiple eTMFs
Ours + partner's
No
Other
2
16
9
16
6
8
4
None Increasedeffort for
reconcilation
Difficultyestablishingfile of record
UserConfusion
Increased costburden
Increasedcomplication
withsubmissionprocessing
Othernegativeimpacts
Issues with more than one eTMF
Reference Model Uptake
2013 TMF Survey #3
Yes 57%
No 36%
unk 7%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2010 2012 2013
unk
no
yes
Model uptake continues to rise
Is your organization using the TMF Reference Model?
Electronic Investigator Site Files
2013 TMF Survey #3
5%
2% 4%
9%
80%
What % of trials have an eISF
76-100%
51-75%
26-50%
0-25%
None
Slight decrease in eISF growth from 2012 survey
7%
2% 6%
13%
72%
Yes - 100%
Yes - 75%
Yes - 50%
Yes - 25%
None
Barriers to eISF uptake
2013 TMF Survey #3
0
10
20
30
40
50
60
70
80
90
43
19 14 11
7
27
90
44
"Other“ response themes
• Planning / building
• Still considering
• eTMF first
• Not there yet
Data and responses very similar to 2012 survey #2
Content not stored in eISF
2013 TMF Survey #3
0
5
10
15
20
25
30
SubjectSigned ICF
Signed Fin.Disclosures
SignedContracts
UnblindedSubject Log
PaymentDocuments
Other(pleasespecify)
26
14
22 22
27
6
"Other“
Source docs
Agency eTMF inspections Refused paper, requested eTMF
Refused eTMF, requested paper
US – FDA 17 1 1
EU – EMA 10 1 0
UK – MHRA 13 6 0
Japan – PMDA 3 0 0
Canada - Health Canada 2 0 0
Australia/New Z – ANZTPA 1 0 0
Brazil – ANVISA 1 0 0
China – SFDA 1 0 0
South Korea – KFDA 1 0 0
Switzerland - SwissMedic 1 1 0
Trends in Health Authority Inspections
2013 TMF Survey #3
Of additional interest, 7 non-premise, remote inspections identified Remote (non-premise) inspection by any regulatory agency / health authority? Y (7), N (18), unk (3)
Contact co-chairs to join TMF Ref Model Team:
– Karen Redding, [email protected]
– Lisa Mulcahy, [email protected]
To stay up to date on TMF Ref Model team progress and active
discussions, read the blog: http://tmfrefmodel.blogspot.com/
join Linked In group “TMF Reference Model” http://www.linkedin.com/groups?home=&gid=2663204&trk=anet_ug_hm
The TMF Ref Model and overview information is free and available
here http://www.diahome.org/en/News-and-Publications/Publications-and-Research/EDM-Corner.aspx
2013 TMF Survey #3
TMF Reference Model – Participate!
• Jennifer Gaskin
• Shah Ashraf
• Suellen Bigaj
• Christopher McSpiritt
• Karen Redding
• Fran Ross
2013 TMF Survey #3
TMF 2013 Survey sub-team – THANK YOU!
