Clinical Trial Activity
Please note the following information is provided as a guidance for clinical trial activity and is based on current limitations set by the FDA and our local Research Administration.
Clinical Trial Office Status
CTC Administrative Support
The Administrative, Start-Up and Finance Teams are currently working remotely. We remain available to provide support and will do our best to avoid delays. E-mail remains the best way to reach the CTC; responses will be sent within 1 business day.
- LLEAP support of ongoing studies and new studies continues to be available, however this is primarily available via e-mail.
- New studies, amendments, and study closures are being processed daily.
- Feasibility meeting are being conducted via Zoom or Skype.
- A new tip sheet for requesting remote access for monitors can now be found on the CTC website.
Answers to sponsors’ frequently asked questions
In general, the CTC administrative staff and our Local IRB are working remotely and continue to maintain operations as close to normal as possible. The CTC continues to work on start-up, amendment and closure processes as required. Our IRB will be conducting their scheduled meetings virtually. Loma Linda University Health is following the guidance provided by the FDA in terms of enrollment and study procedures. This includes limiting the number of required in- person visits to the minimal necessary and conducting study visits electronically or via the telephone whenever possible. It also means continuing clinical research only when the potential benefit of the study outweighs the risks of the study.
Frequently Asked Questions
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Questions |
Response YES / NO (Details as necessary) |
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Is your site currently open and operating as normal?
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No: Changes as noted below. Our site has modified our activity to use established tools to operate remotely whenever possible. Our clinical team remains onsite |
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Have business hours changed? Or are they changing?
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Department: Information to be provided by PI/department CTC: The administrative and regulatory teams are available from 9:00 am thru 3:00 pm. The best way to contact us is via e-mail. |
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Are On-Site Monitor Visits being allowed by site?
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No: Neither on-site monitoring nor external training is allowed currently. |
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Is Remote Data Monitoring (via Telephone/ Skype) being allowed by site?
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Yes: Remote monitoring is available. Telephone and Skype meeting are both possible dependent on the need. Subject Records can be monitored via remote access to monitor electronic medical records. |
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Are there any site restrictions being implemented due the COVID-19 outbreak that affect the continuity of business as normal? (e.g.: telephone restrictions, internet restrictions, patient visit restrictions, data access restrictions, etc.)
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Telephone: There are no telephone or internet restrictions. Subject Visits: Most patient visits are conducted via telephone or via the web. When absolutely necessary in-person treatment visits can be conducted for those treatment and procedures that can’t be done by other means. In-person visits are being shortened as much as possible to lessen the subject’s time in clinics. Electronic or phone visits may be used to obtain surveys or other information required for the visit completion. Data Access: No restrictions, but access limited to electronic means. |
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Does your site have restrictions on the recruitment of research subjects? |
Yes: This is determined on a study-by-study, patient-by-patient basis and the benefit to the subject must outweigh the risk to the subject. We are also following the lead of the FDA guidelines as well as those set out by our IRB. |
Should you have additional questions, please feel free to reach out to the CTC team or the IRB team for IRB related questions.