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STANDARD OPERATING PROCEDURE
Acronyms
Research Administration SOP No: R-Com-203
SOP Title: Internet-Based Remote Monitoring of Non-EPIC Research Data
Children’s Health Research Administration – CHRA
Children’s HealthSM -Children’s Health System of Texas (CHST) and its Affiliates (collectively) EPIC – Electronic healthcare software company
Principal Investigator – PI
Quality Specialist – QS
Standard Operating Procedure - SOP
1. PURPOSE
The purpose of this SOP is to describe the process of review and approval of non- EPIC based research data release via a sponsor’s web-based remote monitoring systems.
2. DEFINITIONS
− Children’s EPIC – Electronic Medical Record system
− Source Documents – Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and any other departments/areas involved in the clinical trial). While most of these documents are located in Children’s EPIC, some of the documents are housed in the patient’s research record which is not a part of Children’s EPIC.
− PHI – Protected Health Information
− HIPAA Privacy Rule – Provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes (such as research).
− Monitoring – The act of overseeing the conduct of a clinical trial and ensuring adherence by members of the local research team per the study Protocol Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
− Centralized/Remote Monitoring – A remote evaluation carried out by sponsor personnel or representatives (e.g., clinical monitors) at a location other than the local site where the clinical investigation is being conducted. Remote monitoring allows sponsor personnel or representatives access to view documents/records that are typically a part of EPIC.
− Web-Based (Internet-Based) Remote Monitoring – With this type of monitoring, sponsor personnel or representatives can be given access to
SOP No. 25, 10-16-2020