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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-203
SOP Title: Internet-Based Remote Monitoring of Non-EPIC Research Data
research data that would normally be “housed” in the patient’s research record and not included in EPIC. Examples include documents that have been reviewed by the principal investigator (e.g. reviewed labs, reviewed ECG reports, reviewed adverse event reports, etc.) and are typically not a part of Children’s EPIC.
3. SCOPE
This SOP applies to all individuals conducting research at Children’s HealthSM.
4. RESPONSIBILITIES
Remote access to EPIC requires a Monitor Access Form to be completed 10 business days prior to the day the access is needed. An account will be created for the sponsor representative for one year. A request to renew is required 10 business days before the account expires. New representatives will be required to complete the same process. All onsite sponsor visits are expected to follow the on-site sponsor guidance attached the back of the SOP. All sponsor representatives coming on site are expected to provide a vaccine attestation and obtain approval to come on site at least 10 business days prior to the day of the visit. Additional requirements extend to representatives that will go into the clinic spaces.
4.1 PI and members of his/her Research Team
Members of the local research team are required to inform CHRA (Research_Department@Childrens.com) regarding sponsor requests to initiate remote or web-based monitoring of local research data. The request needs to be made in advance and requires detailed information as to the type of data that will be monitored by the sponsor personnel or representative.
4.2 CHRA Quality Specialist Web-Based Monitoring
o MembersoftheQualitySpecialistgroupwillquerythelocalresearchteamwiththe following questions:
1. Is the web-based monitoring request a review of sponsor case report forms, PI reviewed/signed lab report, PI reviewed/signed ECG reports, PI reviewed/signed adverse event reports, etc.?
2. Is any data being shared with the sponsor via the remote monitoring system coming from Children’s EPIC or any of its systems?
3. Has the sponsor requested for these documents to be uploaded to a web- based monitoring system?
− If yes, provide the name of the platform and the Internet link: ____________
− Is the web-based monitoring platform compliant with 21 CFR Part 11 and HIPAA requirements?
o The answers to the questions will need to be submitted to the Director of Research Administration for review and approval consideration.
SOP No. 25, 10-16-2020