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Tier 1 & 2

The PNRC administrative office will distribute information provided by the company (e.g., simple survey or questionnaire (Tier 1), or a feasibility questionnaire, non-confidential study synopsis (Tier 2) to our members via e-mail (initial distribution and one follow up reminder). The PNRC will request responses be returned to the administrative office. The administrative office will collect the responses and return to the company in the 6th week from initial distribution.

Summary

1. PNRC distributes study information to member

     ●  1 initial distribution and 1 follow-up reminder sent at beginning of 3rd week post signed agreement.

2.  PNRC collects responses

     ●  Questionnaire must be electronically fill-able.  If we need to create this document please add a minimum of two weeks to time frame.

     ●  The PNRC will collect responses and deliver to the company within 6 weeks.

3.  PNRC will provide a list of sites that did not respond and/or indicated no interest.

     ●  Member sites will not include contact information.

4.  Industry company manages all other aspects of the study.


Tier 3

Feasibility and Site Assessment

The PNRC Services for Industry Engagement for research related to kidney disease in children is as follows:

The Industry company will provide a non-confidential synopsis of a clinical study (“Study Synopsis”) to the PNRC.  The PNRC will submit the Study Synopsis to the PNRC Peer Review Industry Engagement Sub-Committee (PRC IE-SC) for review.  Each PRC member will review the Study Synopsis and evaluate the feasibility of the study, completing the attached PRC Feasibility Scoring form.  This process will take no more than 3 weeks.

Once each PRC IE-SC member has reviewed the Study Synopsis, the PNRC office will distribute the Study Synopsis and the Industry Company Feasibility Questionnaire to our PNRC members via e-mail.  If the PNRC needs to create the electronic fill-able questionnaire, please add a minimum of 2 additional weeks. This e-mail will include the aggregate feasibility score of the PRC. The PNRC will collect the questionnaires, collate the responses and then provide them to the industry partner.

Summary:

1.  PNRC office will submit the Industry company synopsis to the PNRC PRC IE-SC for review.

     ●  Process will take no more than 3 weeks and may be done in person or by email.  If the 3-week time frame does not fall within the PRC regularly scheduled meeting times, the PRC will review by e-mail.

2.  Once reviewed by the PRC IE-SC, the PNRC will distribute the Study Synopsis and the Industry Company Feasibility Questionnaire to our all PNRC members via e-mail.  This e-mail will include the aggregate feasibility score of the PRC. The PNRC will collect the questionnaires, collate the responses and then provide them to the industry partner.

     ●  After initially distributing the Study Synopsis and Feasibility Questionnaire, the PNRC will send two follow up reminders over a Six-week period.

3.  The PNRC will collect and collate the responses and return to the Industry Partner.

     ●  Collect, collate and return responses of feasibility questionnaire to Industry Partner.

     ●  Submit a list of member sites that are not interested or did not respond to email to the Industry Company.  This list will not include contact information.

4.  Industry Partner manages all other aspects of the study and the PNRC has no involvement after it provides Feasibility Questionnaire results to Industry Company.


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