As 2016 winds down we start to look ahead and prepare for the new year. With the elections over, much has been said about what a new administration may mean to pending research legislation, the regulatory landscape, or research funding. Even without a crystal ball, there are several things that a research professional can do now to prepare for the year ahead.
Review and update Standard Operating Procedures (SOPs)
While study site SOPs are not specifically required in FDA regulations, guidelines suggest that they help ensure clinical research sites follow federal regulations, ICH, GCP and institutional policies. SOPs can include provisions for research subject screening and recruitment, data management, adverse events reporting, and more.
BRANY recommends an annual review of SOPs to ensure policy-based regulations are up-to-date.
Additionally, staff should be trained on the SOPs, and the training should be documented. Before calendars get too busy, schedule refresher training for research staff to ensure competency and compliance.
Institutions vary in their requirements for human subject protection training for investigators or research professionals. However, requirements may come from funding agencies or collaborating institutions. Other training may also be required, including HIPAA compliance, conflict of interest, biosafety, and IRB refresher courses. Additionally, the completion of annual continuing education courses may be required in order to meet professional development and/or certification maintenance requirements.
Click here to see a menu of CITI Programs courses approved for CMEs and CEUs as well as CITI’s new courses
Update Essential Documents (Curriculum Vitae, License Information, Lab Certificates)
For long-term studies, it’s important to review and update investigator CVs and licenses in the regulatory binder. Review investigators’ medical licenses and update the documentation if they have expired.
The FDA has been clear in its guidance that IRBs “must review the qualifications of clinical investigators who conduct FDA-regulated research.” Even if the members of the IRB are familiar with the investigator’s background, many sponsors will require updated CVs to ensure the investigators are “qualified by training and experience as appropriate experts.”
While your CLIA or other lab certification may not come up at the end of a calendar year, it is important to ensure your certification is up to date and note on the calendar when it is time to renew. CLIA certification is effective for two years.
Monitor your Delegation of Authority Log
If you add a new investigator to a trial, or hire a new research coordinator, you must document the addition of any key personnel in your Delegation of Authority Log. This information must also be submitted to the IRB.
With busy schedules, it can be tempting to wait for monitors to flag concerns. But it’s important to be proactive. Conducting a spot check every six months and a more detailed annual audit may protect you from panicked scrambling in the days before an announced FDA visit. Also, if an inspector finds an issue with one clinical trial, the investigation may extend to your other trials. And that is the kind of headline-making news you want to avoid.
Prepare for Accreditation Renewal
Whether you are an AAHRPP-accredited site or have accreditation from another organization, you will likely be required to prepare an annual report or possibly prepare for re-accreditation. Annual reports for AAHRPP serve to notify the organization of any changes that might impact the organization’s Human Subject Protection Program, including changes to the organization, resources or programs.
Amid the end-of-year holiday parties and a general sense of relief that the year is winding down, there is still much left to do to prepare for the new year.
Year-end can also be a time when organizations assess what resources they have and how efficiently they are being utilized. In our experience the work patterns in research ebb and flow. At times organizations may need additional staffing support, but lack the ability to bring on additional staff. More and more organizations are looking to supplement their staff needs with outsourced services. When tasks like contract negotiation, budget development, coverage analysis preparation, regulatory document prep and IRB submissions can be outsourced, the staff on site then have more time to focus on carrying out the study, and recruiting and retaining patients in clinical trials.
What is your institution or research team doing to prepare for the new year? Do you have any New Year’s resolutions for how you will be more efficient or how you will stay on top of regulatory or compliance requirements?
Share your story with us!