How can we use RISC in our Research Projects?

RISC is set up as a support service group. While we charge fees for services we are not for profit and utilize economy of scale to provide reasonable prices for our services. We usually by in the proposal stage of research where we work with the PI to present the best possible model for the RFP. Please Contact us to find out more about RISC.

How can new information technologies improve the conduct of multi-site clinical trials and epidemiological studies?

Multi-site research requires the successful collection and integration of data for decision making at all phases of the project, from subject recruitment and screening to the testing of primary and secondary hypotheses. With the advent of the World Wide Web and accompanying processing languages such as Java, Visual Basic and XML, it is possible to create applications that can standardize not only data entry and cleaning procedures at multiple sites, but also ensure the proper execution of algorithm-drive decision processes, and establish central ‘command and control’ by monitoring subject accrual, data completeness, scheduling of follow-up examinations and other critical research processes.

An example of web-based control of research decision-making is provided by an application developed by RISC, which can be found at the WWW page http://www.riscdata.org/prepare/. The site, designed by Howard Andrews PhD and programmed by Chandresh Shah, was created to assist in screening subjects for a multi-site clinical trial, Alzheimer's Disease Prevention Trial with Estrogens (Principal Investigator, Mary Sano, PhD), with support from the Washington Heights-Inwood Columbia Aging Project (Principal Investigator, Richard Mayeux, MD).

What are the rules governing electronic data and safety monitoring?

In 1999 the FDA issued the Electronic Records, Electronic Signature Rule (ER/ES - 21 CFR 11). and the newly published Guidance on Computerized Clinical Trials. These rules and guidelines establish stringent requirements for software systems used for the collection of clinical trial data. Among the key requirements cited by the FDA are concerns for full audit trails, user authorization and signature controls.

In October, 2000 The National Institute of Health issued revised guidelines regarding data and safety monitoring requiring oversight and monitoring of all intervention studies to ensure the safety of participants and the validity and integrity of the data. The policy further elaborates that monitoring should be commensurate with risks and with the size and complexity of the trials. The revised policy, which can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html, states that these stringent guidelines must be made applicable to all Phase I, II and III clinical trials.

The RISC Group has been monitoring these and other government oversight initiatives with respect to the use of electronic data in clinical trials, and all RISC projects are in fully compliance with existing regulations.

How can this technology be used to manage large-scale projects in which well-specified research procedures must be applied uniformly across geographically dispersed work sites?

To maximize the efficiency of research efforts, large-scale projects typically have the following attributes:

• Subjects and evaluation sites are geographically dispersed
  
• Complex data is collected on subjects at multiple points in time
  
• Follow-up evaluations are contingent on the results of previous testing or information

To meet this challenge, the RISC group is working closely with Dr. Dolores Malespina on the Jerusalem Study, which involves an intensive follow-up of the medical, psychiatric and genetic status of approximately 1,700 Israeli subjects. The project requires linking existing computerized health and administrative data as well as the collection of project-specific information, including laboratory analysis of blood samples, and a review of medical records by research staff using the Diagnostic Interview for Genetic Studies (DIGS).

The management of this project presents a significant logistical challenge. The first obstacle is geographic: the source of all research data, both existing and new, is Israel, while data management and overall project management will be based in the United States, at the New York State Psychiatric Institute. The second administrative challenge is monitoring the acquisition of project data: there are multiple sources of data for each subject, not all data will be collected on all subjects by the DIGS, for example, will be administered to only 200 individuals and each type of data will be collected by a different team of researchers.

To provide for strong central oversight and management of the project, the RISC Group is developing a web-based project management system. The main purpose of the system is to provide a resource documenting and reporting the accrual of project data, together with subject demographic information and key indicators, or abstracts of each data type. The features of this system include:

• Establishment of a secure web-based administrative database
  
• Access to the administrative database is possible only to authorized staff using particular PCs; security will be assured through a combination of technologies, including token cards, passwords, multiple levels of access, and encryption.
  
• All 1,700 study subjects are >pre-registered= in the database, using a 10-digit encrypted identifier. Demographic information from existing records are entered together with the ID. It is not possible to add information to the database until there has been confirmation that the encrypted ID entered by a researcher matches one of the 1,700 Ids stored in the database.
  
• For each type of project-specific data that is collected, a data entry screen captures relevant information about data acquisition. For example, the Blood Specimen screen will be used to record the name or initials of the researcher drawing blood for a particular subject, the location of the blood draw, the number of tubes (ml) of blood obtained, the location of the laboratory where the blood is stored, and the laboratory ID number that has been assigned to the specimen. The data entry screen for DIGS will record the date the review was completed, the name of the reviewer, and a small number (no more than 20) critical diagnostic and medical indicators contained in the DIGS instrument.
• A series of programmed administrative reports can be generated automatically on a daily basis. These reports will summarize the accrual of data, and will include an overall summary (e.g. for how many subjects has blood been drawn, for how many have chart reviews been completed) and breakdowns by demographic and other relevant subgroups (e.g. are phlebotomists as successful drawing blood from older as opposed to younger subjects; how many blood draws have been done at Hospital A compared to hospital B). In addition, there will be detailed reports in spreadsheet form, summarizing the accrual of data for each individual subject; in this report, each row will represent one subject and each column will indicate the presence or absence of a particular data type. Finally, there will be reports summarizing subjects who have a certain combination of data, but are missing other particular data types. The content and number of these reports will be specified by the principal investigator and the research staff.
  
• The principal investigator determines which project staff can have access to the administrative reports. In some cases, a particular staff member may have access to one group of reports but not to others. Staff-specific access will be controlled via passwords, based on authorization established by the principal investigator.