E-Rare-3 JTC 2016 – Preclinical Annex Application Form
All fields must be completed using "Arial font, size 11" characters single-spaced, margins of 1.27 cm.
Please note that incomplete full-proposals, proposals using a different format or exceeding length limitations of any sections will be rejected without further review.
Proposals that do not meet the national eligibility criteria and requirements will be declined without further review.
All the information requested in this document must be compiled into one single Pdfdocument and uploaded to the electronic submission system.
In case of inconsistency between the information registered in the submission tool and the information included in the PDF of this application form, the information registered in the submission tool shall prevail.

E-Rare-3 JTC 2016 – Preclinical Annex Application Form
1a. Background and present state of the art in the research field (max. 2 pages)
1b. Preliminary results obtained by the consortium members ( max. 2 pages)
2. Description of the aims
Aim No. Description
1
Partner(s) responsible for the aim / workload
2
3
4
N
3. Workplan (max. 5 pages), it must contain:

Description of the working program including the objectives, the rationale and the methodology, highlighting the novelty, originality and feasibility of the project;

Clearly defined responsibilities and workloads [expressed in person months] of each participating research partner, time plan, including project coordination and management;

References

Diagrams and figures

Description of animal studies (if applicable) in accordance with the suggestions of the ARRIVE-
Guidelines 1,2 .
1 The ARRIVE Guidelines: Animal Research: Reporting of In Vivo Experiments. Originally published in PLOS Biology, June 2010
( http://www.nc3rs.org.uk/arrive-guidelines )
2 Animal studies
In case animal studies are planned, comment on the items below considering the ARRIVE Guidelines .
Background and objectives:
Explain the experimental approach and rationale; and how the animal model being used can address the scientific objectives, explain the study’s relevance to human biology.
Methods: a.Study design (number of experimental and control groups, steps to minimise the effects of subjective bias, experimental unit) b.Experimental procedures (drug formulation and dose, anesthetic and surgical procedures, equipment – How, When, Where,
Why) c.Experimental animals (species, strain, sex, developmental stage, age, weight, source of the animals, genetic modification status, etc.) d.Housing and husbandry (type of facility e.g. specific pathogen free [SPF]; type of cage or housing; bedding material; number of cage companions, type of food, access to food and water, environmental enrichment etc.) e.Sample size
•specify the total number of animals used in each experiment, and the number of animals in each experimental group
•explain how the number of animals was arrived at
•provide details of any sample size calculation used. Indicate the number of independent replications of each experiment, if relevant f.Allocating animals to experimental groups (details of how animals were allocated to experimental groups, including randomisation or matching if done; order of treatment and assessment) g.Experimental outcomes (define the primary and secondary experimental outcomes assessed e.g. cell death, molecular markers, behavioral changes) h.Statistical methods
•provide details of the statistical methods used for each analysis

E-Rare-3 JTC 2016 – Preclinical Annex Application Form
Please use the following table for detailing the distribution of work in person months (PM) in different tasks
( adapt as necessary ):
No.
Research
Partner
(principal investigator)
Task1
(PM)
Task2
(PM)
Task3
(PM)
Task4
(PM)
Task5
(PM)
Task6
(PM)
Taskxx
(PM)
SUM
2
3
4
5
6
7
8
9
10
(only possible with inclusion of Eastern
European partner)
(only possible with inclusion of Eastern
European partner)
(Associated partner 1)
(Associated partner 2)
SUM
4. Diagram that compiles the work plan, timeline, sequencing of Tasks, the contribution of the partners to each Task and their interactions (max. 1 page)
•specify the unit of analysis for each dataset (e.g. single animal, group of animals)
•describe any methods used to assess whether the data met the assumptions of the statistical approach

E-Rare-3 JTC 2016 – Preclinical Annex Application Form
5. Financial plan: sum of year 1-3. Please describe the requested budget only.
Acronym:
No.
Partner 1
(Project coordinator
Partner 2 Partner 3 Partner 4 Partner 5
Name (principal investigator)
Partner 6
Partner 7
(only possible with inclusion of Eastern
European partner)
Partner 8
(only possible with inclusion of Eastern
European partner)
Funding organization
Person Months , € (1) *
Person Months , € (2) *
Person Months , € (3) *
Person Months , € (4) *
Personnel total €
Consumables €
Equipment €
Travel €**
Other direct costs €***
Overheads €****
Total funding € requested
* Please detail number of person months (PM), qualification ( Si : scientist, e.g. postdoc; PhD : PhD-student; N : non-scientist, e.g. technician; Ot : other) and € requested. Please use one cell per person to provide this information. Please note that students are funded according to national regulations
**Travel expenses should include the participation of the coordinators and/or national partner leaders at an intermediate and/or a final status symposium to present the results of their projects (organized by the Joint Call Secretariat)
***e.g. subcontracting, provisions, licensing fees; publications; clinical trial drugs/compounds, clinical fees and insurance. Some may not be eligible costs in all countries (will be handled according legal framework and funding body regulations)
****Overhead costs: funding according to national legal framework and funding body regulations. Please refer to the guidelines for applicants for full proposal application form

E-Rare-3 JTC 2016 – Preclinical Annex Application Form
6. Scientific justification of requested budget (rational distribution of resources in relation to project’s activities, partners responsibilities and time frame; please also specify co-funding from other sources necessary for the project if applicable) (max. ½ page per research partner)
7. Ethical and legal issues - according to national regulations if applicable (e.g., data protection, use of animals in accordance with the suggestions of the ARRIVE-Guidelines 3 )
Date and signature of coordinator
3 The ARRIVE Guidelines: Animal Research: Reporting of In Vivo Experiments. Originally published in PLOS Biology,
June 2010