Sop clinical trial monitoring

Please note all information included in this article is for the purpose of examples and not intended for specific client use without further consultation. The guidance is clear. Regardless of deviations, sites can utilize remote monitoring to prioritize participant safety and data. Who does this apply to, what do we update, and how do we update it? First, who does this apply to? There are two main SOP components to consider when remotely monitoring and managing clinical trial documentation: access control and communication.

Most likely, you already have language in your SOPs stating how the regulatory binder or trial master file is accessed by team members, monitors, and auditors. The language may include a filing cabinet with lock and key or a biometric-accessed binder room. Here are five things consider to update your access control SOP for remote management:.

Answering these questions in your SOP updates will maintain the integrity and audit trail of the documents accessed and managed as thoroughly as possible. Most likely, you already have a current plan in place for how you and your team members are communicating while remote. Next is identifying the standard way in which you are exchanging documents and collaborating about changes and updates.

A standard plan and channel for these types of communication will ease the burden on your team, eliminate duplicative effort, and prevent compliance risks of missing or outdated information. Lastly, we get tactical. How do we update the language? Here are a few examples of SOP language for both sites and sponsors regarding universal remote access as well as remote monitoring:.

Navigating these new and continuously evolving times can be tricky. Still, the key to easing the burden from your team is as transparent as possible about the process and ongoing adjustments to maintain the integrity and compliance of your clinical trials.

Toggle menubar The Florence Learning Library. Open search box. Search sitewide Close search box. Communication about deviations across studies, teams, and IRBs help coordinators prioritize and respond to deviations more quickly. A cloud-based technology platform can easily facilitate this process. The safety of the participant always comes first, which is highly emphasized throughout the guidance.

When some or all staff are working remotely, an intuitive workflow can significantly help maintain participant safety and data integrity. A remote tool like eRegulatory offers the ability to communicate about deviations promptly. Here are five things consider to update your access control SOP for remote management: Who will be accessing those documents?

Ex: Internal team members all or specific roles , external team members monitors, auditors, third parties What types of documents will be accessed remotely? Characterizing Disease. Researcher Resources. Dengue Fever. Shiga Toxin-Producing E. Researching Ebola in Africa. Photo Essay. Food Allergy. Research Approach. Treatment for Living with Food Allergy.

Fungal Diseases. Group A Streptococcal Infections. Vaccine Research. Types of Group A Strep. Vaccine Development. Basic Research. Leprosy Hansen's Disease. Lyme Disease.

Antibiotic Treatment. Chronic Lyme Disease. Featured Research. Types of PIDDs. Talking to Your Doctor. Therapeutic Approaches. Animal Prion Diseases and Humans. Rocky Mountain Spotted Fever. Schistosomiasis Bilharzia. Tickborne Diseases. Tuberculosis Drugs. West Nile Virus. Addressing Zika Virus. Types of Funding Opportunities. See Funded Projects. Sample Applications.

Determine Eligibility. Prepare Your Application. Additional Application Elements. Research with Special Considerations. Submit an Application. Track Your Application. Understand the Review Process. Respond to Pre-Award Requests. After Award. Contract Solicitations. Contact the Office of Acquisitions.

Most Recent Edition. Browse by Edition Date. Search All Funding News. Clinical Trials. Find a Clinical Trial. Participant's Guide to Clinical Trials. Participant Testimonials. Laboratory of Infectious Diseases. Primary Immune Deficiency Clinic. Vaccine Research Center Clinical Studies. Vaccine Clinical Studies Safeguards. News Releases. Media Contacts. Media Resources. Fauci in the News. Congressional Testimony. Past Events. Kinyoun Lecture Series. LaMontagne Lecture Series. Hill Lecture Series.

Director, Anthony Fauci, M. Profiles, Awards and Honors. Laboratory of Immunoregulation. Previous Directors. Office of the Director. Division of AIDS. Division of Allergy, Immunology, and Transplantation. Division of Microbiology and Infectious Diseases.

Division of Extramural Activities.