NINDS Assistance and Assurance Visits

The National Institute of Neurological Disorders and Stroke (NINDS) has contracted with KAI Research, Inc. (KAI) to perform external reviews of clinical and statistical coordinating centers and of central laboratories and reading centers to evaluate the study investigators' readiness to initiate a trial, to review the study's progress, and to identify areas that may require additional assistance, such as patient accrual and retention, data management, and study leadership and communication.

The NINDS processes, from establishing an initial site visit through post-visit follow-up, are outlined for investigators in the site visit scenario flow  (PDF, 25 kb).

Typically, NINDS requests that KAI conduct a clinical trial review prior to study participant recruitment to ensure that all study activities comply with the protocol and Government regulations, the study is prepared to commence with recruitment/enrollment, data collection procedures will result in data that are timely, accurate and consistent, and study participant safety and confidentiality will be maintained. Specifically, reviews can focus on one or all of the following areas, depending on the study stage:

• Study Procedures including adequacy of the Manual of Procedures (MOP), data management procedures, audit trails, software validation, drug handling, and quality control procedures.
  
  
• Study Operations including adequacy of the plans and procedures for study participant recruitment, eligibility assessment, enrollment, compliance, and retention; informed consent procedures; data flow; adverse event reporting from the clinical sites; central laboratory and, therapy distribution center processes; the roles of the study sponsor, the NINDS, and the Data and Safety Monitoring Board (DSMB); and intra-study communication and coordination.
  
  
• Clinical Data Management assessing accuracy and reliability of the forms' contents.
  
  
• Study Databases ensuring consistent and accurate representation of data.
  
  
• Technical Reports ensuring that content accurately reflect the study findings.

To prepare for a site visit, KAI obtains and reviews the study protocol, forms, and other materials to become familiar with the study. A site visit is then scheduled with the Principal Investigator (PI) and his/her staff for a mutually agreeable time. These visits may include a representative from NINDS as well. The focus of the visit depends upon the study stage. To assist the PI and study staff in preparing for the site visit, NINDS and KAI staff have developed the Data Quality Checklist for NINDS Investigators to Conduct a High-Quality Research Project [MS Word version] [PDF version ] to guide the PI on the possible topics that may be covered during the visit. It is NINDS's expectation that study staff have taken each of the activities into consideration prior to the actual visit date. A draft agenda covering these topics will be shared with the PI and the NINDS Program Director responsible for the study prior to the visit. KAI, and the NINDS representative when in attendance, will talk with the PI and other study staff so that there is an understanding of roles, responsibilities, and study operating procedures.

After the site visit, KAI will prepare a report for the PI, and if applicable the NINDS representative, for comment/clarification. In addition to summarizing the site visit, the report may include recommendations for comment by the PI. Once the document is finalized with the PI comments, it will be sent to the NINDS Program Director who oversees the study.

Additional correspondence or a follow-up visit may be conducted by KAI and or NINDS once the PI has received a copy of the external review report and has had opportunity to implement the recommendations.