OASIS Comments

Oasis Review

Comments submitted by : J.J. DeSanti – CEO, PharmaVigilant

Comments/Questions:

1) Non Normative References – 13 are listed however

Question: What is the % breakdown of the contributions by participant?

2) Open system standards-

Question: Who has ownership regarding the review and update process? What is the conflict resolution procedure? And what is the frequency of the review/update?

3) Page 9-

Question- How is clinical trial development time lines accelerated with interoperability exchange?

4) Page 9

Question: – Agency compliance in USA is eCTD, how is this supported?

The documentation states that a yes/no is applied to the data items, however this is not a supported export.

5) Page 9-

Question: How is SAE exchange supported?

6) Page 10-

Question: How are CCS and MVI updated? Who is responsible and what is the frequency? How do we ensure version control among users?

7) Page 11- MVI

Question: What industry groups are identified?

Frequency and conflict resolution need to be addressed.

8) Page 14

Question: Classification categories – has this been compared to large global trials that break down information by region/country?

9) Page 15

Question: Original code for categories and context types must be maintained along with abbreviated names. Does it have to convert to original code and category for interoperability – maintaining both? How is this archived?

10) Page 16

Question: Organization specific classification and content is not easily handled with interoperability. Importing party is responsible for checking? Is there a standard process defined as well?

11) Page 20-

Question: Organization specific metadata is not added. If the organization information is added, then what metadata is included?

12) 6.1 Page 26

Question: There are more file types than XML and PDF. How do we handle images such as DICOM, MP3 (audio training files), or MP4 (video training and or procedure files).

13) 6.1.1 Page 26

Question: Identification of eCTD data items as yes/no, does not address the need for eCTD format exports in the USA. What is the plan for an eCTD format within OASIS interoperability?

14) Page 27

Question: Define OASIS folder taxonomy? Who controls it? Who updates it? What is the review process and the frequency?

15) 6.2- Page 27/28

Question: The current document addresses digital signatures, but not electronic. How does the standard address electronic signatures and or wet signatures scanned (corresponding metadata).

Electronic signatures are user/password protected, so they are verified in the system it is not 2 factor verification. If the industry standardizes on a 2 factor signature verification, the cost of implementation and maintenance is extensive. This would dilute the initial statement that standards would accelerate clinical trial development time lines and cost. The number of digital users would expand exponentially. This solution is migratory at best, and will slow adoption once the industry understands the cost of implementation.

16) 6.3 Page 28 –

Question: What if there are multiple status steps within the work flow such as multiple approvals? How is this handled?

Currently we support multiple status changes to accommodate work flow – OASIS needs to address this as it would need to capture the process change in order to understand hierarchy and how to implement the standard.

17) Page 32- Business Process-

Question: Date of signing? Server date/time stamp or local? How is this handled?

18) Page 33- Core/Source

Question: identifies fax as a source? How is the metadata handled in this instance?

19) Page 33 –

Comment: Organization name should not be included. This will cause confusion unless it can be taken to a granular level. For example: a global organization such as Quintiles, how do I use or tie back this information with large global companies?

20) Page 33-

Question: Why does document not contain time?

Documents must contain user/date/time. Time is important and must be included along with date.

21) Page 34 – Core Metadata – Content identifier – images

Question: How do you handle large volume image studies regarding numbering? (i.e. 2M images?). 20K subjects x 100 images get you there

22) Page 34 –

Question: What about DICOM, MP3, MP4, PET scans? How is this handled?

23) Page 35 –

Question: Electronic signatures are not defined yet dominant in the industry compared to 2 factor signatures. How do we handle this in the interim until industry transformation occurs?

Comment: It is not being properly addressed as it is pushing a digital signature strategy.

24) Page 35 –

Comment: Credentials – Include everyone (all credentials) or include no one is the safe way to go. Needs to be dropped.

25) Page 35 –

Comment: eCTD is insufficient. Needs to be addressed.

26) Page 37

Question: Codes – Codes with Y reviewed by Carelex? Does this mean that Carelex will maintain ownership and oversight going forward?

27) Dublin Metadata –

Comment: this is outdated and does not reflect an electronic environment. For example, they have 2 examples of images, 1) Image, and 2) Still image. We deal with a myriad of types and it is important to delineate them in order to determine the size and complexity of what we are dealing with. PDF’s and JPEG are not the same to handle as complex DICOM or PET scans. Dublin could be used as a baseline, but the content needs to be seriously updated to reflect the status changes, and granularity that electronic systems can provide. Too high level for reporting purposes in today’s environment.

28) Comment: Standards should be objective and as inclusive as possible in order to promote compliance. The OASIS standard needs to produce use cases that will support industry adoption. The lack of use cases will result in the standard drifting, as the true owners (sponsors) will not be able to internally provide justification for the initial and on-going cost of ownership. SOP’s, work instructions etc. will have to be re-written, training will have to take place on a global level - the case that cost reductions will come is understood, however without providing metrics, falls into the greater good category, which is difficult to defend within sponsor’s financial reviews.

James J. DeSanti

CEO

PharmaVigilant

508-667-2294 (Mobile)

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