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Remarks EU

a) ESR: Remarks

1. Clarify how the closed loop is implemented and how feedback is given to patients.

A few sentences added to the introduction and overall aim.

2. A more detailed breakdown of resources (staff, equipment, consumables, etc.) needs to be provided.

Inserted a new table.

3. A verification of the diagnosis (distinguishing between major and minor depression) needs to be made prior to patient inclusion in the validation process.

A part has been added in WP5.

4. Provide details on the rationale for the selection of biomedical parameters and related sensors.

The proposal already says: o From what is already known form the literature, for the preliminary tests referred above we envision the development and application of sensors for electrodermal activity (which reacts to attentive, cognitive and emotional or stress states), respiration, and electrocardiography, from which the heart rate can be obtained.

5. Clarify the necessity for obtaining CE marking.

Explained following the input from PLUX.

6. Justify further the need for subcontracting the development of prototypes and the web-based questionnaires.

Forwarded the question to Bernard, and Pim has already requested Heleen to answer this question for Trimbos. The explanation of Bernard has been added to the Annex (electronic and mechanical development of hardware in three phases: electronical hardware and firmware , mechanical design and electronic integration, industrial tooling for pre-series production)

7. Clarify how the consortium will deal with interoperability issues related to the devices of the system and other e-health systems such as electronic health records.

In WP4 text has been added how this will be accomplished based upon the remarks of Pim sent by email.

b) ESR: Criteria comments

8. Operational procedures (e.g. decision making, conflict resolution, quality control, etc) are not clearly described.

9. The allocated management resources are not adequate to run the proposed project.

Have been kept constant whereas the other parts have decreased. Furthermore, text has been added about the other partners that contribute from their own budgets.

10. It would have been beneficial if more concrete routes were sought for the overall system exploitation.

Seperate WP now, in which more concrete routes can be described.

c) Additional comments on the proposal

11. Deliverables list: Add Person-months for each Deliverable.

Added an additional column, the information is still to be added.

12. Deliverables list: 59 Deliverables is a lot. Consider to group some Deliverables together and the relevance of some?

The list has been reduced in size now. Maybe the deliverables for WP4 can still be reduced?

13. Deliverables list: Consortium Agreement should not be a Deliverable. A Consortium Agreement must be signed before the Project's Grant Agreement is signed, but it is not required to submit a copy to the Commission.

Removed it from the list in both the WP as well as the total deliverables list.

14. Deliverables list: Minutes from consortium/WP leader meetings should not be Deliverables.

Removed it from the list in both the WP as well as the total deliverables list.

15. D6.7: detailed planning for next 18 months is not required.

Ok, removed that part of the deliverable.

16. Deliverables list: No deliverable can have a Delivery date beyond the project duration (month 1-36).

Ok, changed some of the dates to fit within this schedule.

17. Several tasks have only one contributing participant with seemingly many person-months. To be clarified.

18. What is the content of the Midterm report (D6.8 in month 20) in comparison to the yearly progress reports?

Nothing more, so we removed it.

19. D5.4: specify which study.

Done, now specified as the open study with the system.

20. WP1: All modules in task 2 do not seem to have a corresponding Deliverable.

Combined it into one.

21. In WP6: All partners are involved in several tasks, but only Partner 1 has any planned person-months.

Explanation has been added.

22. Dissemination and Exploitation: Provide more specific tasks in the relevant WP.

Added a WP.

23. Consider a separate WP for Dissemination and Exploitation.

A seperate WP template has been copy-pasted in there, the content of the other WP's regarding the dissemination has been added.

24. Ensure all tasks are during the planned project duration (i.e. WP 6, Task 5 describes activities that will be done before the start of the project).


25. Provide effort table with planned person-months by task and by partner.

Done for some parts, not complete yet.

26. Who is the Project Manager?

According to Rene a postdoc can for instance be used. Who is tbd. Maybe Pim knows somebody?

27. Individual participants: For each participant there should be a sub-title with a short paragraph clearly indicating the participant's main tasks in the project, as well as the previous experience relevant for these.

Added the subtitles, only for some information still needs to be added. We can ask the partners to do this.

d) Regarding concertation and dissemination activities, the project should plan and account for the following:

Accorinding to Paul, these should just be integrated in the text.

28. Participation in concertation activities with other ICT funded projects related to the area of the project and organised by the European Commission. Please ensure that appropriate resources are available for concertation meetings.

Added to dissemination of scientific results.

29. Involvement in targeted dissemination actions and international events, especially medical conferences and publications in medical journals. Please identify which are the most important events for you in 2010-11. The project may also be requested to represent the Commission at some international events.

Some conferences added (Medinfo, MIE, AmI, HEALTHINF) + BMC Health Services Research journal.

30. The project website should be kept updated with news, public deliverables, articles and material from participation at events (e.g., slides of presentations, keynote speeches, articles in journals and conference proceedings).

Added to text.

31. There must be a clear acknowledgement of EC funding in all disseminations activities, at any media or event (e.g., website, brochures, articles, presentations).

Added to text.

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