3 - Specific competencies and capacity to provide export advice
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PEDSTART - French national paediatric research network |
|
| Number of peer reviewed publications in the last 5 years | 1 | 1. O.L. Mantha, F. Flamein, M. Turner, R.M. Fernandes, R. Hankard, and Network of National Networks Study Group, Early Impact of SARS-CoV-2 on Pediatric Clinical Research: A Pan-European and Canadian Snapshot in Time, The Journal of Pediatrics. (2021). https://doi.org/10.1016/j.jpeds.2021.08.028 |
| Number of competitive grants obtained in the last 5 years | 4 | This publication has been led by a member of the coordination team |
| Access to expert groups | Yes | All members of PEDSTART network are involved in French (French paediatrics society, French Neonatology society) and European specialty learned societies (such as ESPGHAN). PEDSTART has many connections with experts groups, and it covers large areas due to the diversity of its member’s specialty. |
| Capacity to answer external scientific questions | Yes | PEDSTART schedules a monthly steering meeting to discuss any new trial and ongoing studies. If any project requires an expertise, or if the network is solicited on a specific question, additional meetings (teleconference and/or face to face) should be planed within a month by a PEDSTART project manager (attendees are listed according to the specialty discussed). It may also include several F-CRIN-labelled partners. All scientific questions should be emailed to the PESTART SPOC and we will respond or forward requests to appropriate parties. |
| Site feasibility | Yes | Each CIC follows their own standardized procedures for assessment of site feasibility. These SOPs are not publicly available. PEDSTART has a SOP in place for managing incoming feasibility requests. The network acts as a single point of contact for sponsors or third parties wishing to approach the French sites for feasibility. The network acts as a facilitator. It review the feasibility request, forward it to the sites, collect all the responses from the sites and is responsible for informing the sponsor or the third parties on behalf of the sites, according to the deadlines. This SOP is not publicly available but PEDSTART members or others interested parties could have access to it on request. |
| Participant recruitment | Yes | In each CIC there is dedicated staff to monitor the recruitment of all project. At least 3 systematic monitoring visits are carried out: a visit at the beginning of the study, one at the end and a visit during the study. Central monitoring for all trials (once a month) regarding inclusion, quality control of the data (missing data, missing visits, uncomplete items in the CRF, protocol violations, Adverse events) are also carried out on regular basis. Each paediatric CIC has its own SOPs. The SOPs are not publicly available. |
| Budget calculation for studies | Yes | Cost estimates are made when a study is proposed. The quote is made based on the time spent on projects. Each CIC holds a procedure for the conformity of time spent on the project and the financial plan. In order to harmonise the system a unique financial contract between PEDSTART participants will be available soon. PEDSTART will use the general F-CRIN contract system in order to promote the network system. Trials’ costs will be estimated by clinical Investigation units and then be verified by PEDSTART coordination team for all new studies proposed. The SOPs are not currently available. The SOPs are not publicly available. |