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ABX Study: Manuscript Development Process SOP

The purpose of this Standard Operation Procedure (SOP) is to establish a uniform process for PCORnet studies to follow when developing manuscripts and defining and contracting participating authors.

LikeMadelyn McKeague Added November 9, 2018

PaTH: Retaining Local Perspectives in the Era of the Central IRB – The PaTH Network Protocol Review Committee Poster

As currently implemented, the single IRB process means valuable input from both institutional as well as patient and community resources of ceding sites is lost. The PaTH Network aims to develop and implement a process to ensure local patient input in research protocols reviewed under the single, or central, IRB model.

LikeMadelyn McKeague Added November 7, 2018

PaTH: A Multi-Site Review Process that Retains Local Patient Involvement in the Era of the Central IRB Abstract

The PaTH CDRN has developed a pre-IRB review process that incorporates input from all involved sites and their patient partners, enabling all stakeholders to help craft final research plans. Patient partners included in such a pre-IRB review often identify issues that are distinct from those raised by IRB members or by patients who work with specific research teams.

LikeMadelyn McKeague Added November 7, 2018

PORTAL and OneFlorida: ‘Safety of Direct Acting Antivirals for Patients with Hepatitis C Virus’ Research Request Form

The ‘Safety of Direct Acting Antivirals (DAA) for Patients with Hepatitis C Virus (HCV)’ project examined whether patients with HCV who are prescribed newer DAA medications experienced higher rates of adverse events than patients with HCV who are untreated.

LikeDonna Woo Added November 6, 2018

PORTAL and OneFlorida: ‘Safety of Direct Acting Antivirals for Patients with Hepatitis C Virus’ Adverse Events Definitions

The ‘Safety of Direct Acting Antivirals (DAA) for Patients with Hepatitis C Virus (HCV)’ project examined whether patients with HCV who are prescribed newer DAA medications experienced higher rates of adverse events than patients with HCV who are untreated. The project team is sharing the list of the adverse events and definitions (e.g., ICD-9 and ICD-10 codes) used in this study of the safety of a specific medication. It can be used by others who are studying these types of adverse events.

LikeDonna Woo Added October 16, 2018

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