A study that involves more than minimal risk (reviewed at the full board) will have additional requirements depending on the level of complexity. Ī study that involves no more than minimal risk will require a plan to protect data and ensure the safety and confidentiality of research participants. The Data and Safety Monitoring Plan (DSMP) should be based on a risk assessment of critical data and processes that are necessary for human participant protection and integrity of the investigation.

Monitoring enables study teams to identify and correct any deficiencies in the conduct, record keeping, or reporting. Monitoring, an ongoing process of overseeing the progress of a study from start to finish, is a quality control tool for determining whether study activities are being carried out as planned and whether there are any unexpected safety concerns. Upload the email in the study history for our records.Įvery study requires a plan with some level of data and safety monitoring. Please refer all questions to studies taking place at Grady: email the device and data use information to the Grady privacy officer, D’Andrea Morning, at for her review and approval. Use a Part 11-compliant platform for FDA-regulated studies!įor studies taking place at Children's Healthcare, please log in to their intranet (Careforce) and access this CareforceConnection document for information on how to submit for security review.NOTE: if using RedCap, use their eConsent framework!.Use of Electronic Informed Consent (PDF) Revised on.Email encryption information (from OIT): email encryption is required if emailing sensitive information to people outside Emory or consents (even if empty) to study participants.Mobile Medical apps worksheet (DOCX)(also in 'Drugs, Devices, and Other FDA Regulated Products' section below).Emory Zoom Account Type (PDF): HIPAA-compliant vs.OIT approved apps for research: Find a complete and updated list on the OIT website.When is a OIT security review needed? Guidance to help you determine if you need an OIT security review when using a software or app for research.

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