Built in to each EDC form is the logic to enforce skip-outs to bypass unnecessary questions, alerts to indicate potential problems with the data, and automated scoring to provide real-time feedback. The ASPECT EDC platform can be configured with any of the available ASPECT forms, or custom EDC forms can be created for ASPECT.
The DIGS is the result of a National Institute of mental Health (NIMH) initiative, and was specifically based on the problem of the definition and the assessment of the phenotype in psychiatric genetics, regarding inconsistent and non-replicated findings. The DIGS is a clinical interview especially constructed for the assessment of major mood and psychotic disorders and their spectrum conditions. The DIGS should be useful as part of archival data gathering for genetic studies of major affective disorders, schizophrenia, and related conditions.
A collection of short rating scales, tests, and measures that may be useful for diagnosing and caring for patients with mental illnesses, including the BPRS, BDI, BASIS, CGI, ISS, MMSE, SANS, SAPS, HAM-D, and YRMS.
The Family Interview for Genetic Studies (FIGS) was developed by principal investigators in the NIMH Schizophrenia and Bipolar Disorder Genetics Initiatives and NIMH extramural program staff as a guide for systematically collecting information about relatives in family/genetic studies of these disorders. Unlike the DIGS, the FIGS does not elicit self-report data; rather, subjects are asked to provide information about others. FIGS administration proceeds in three steps: 1) a pedigree is drawn and reviewed with the informant; 2) general screening questions are asked in reference to all known relatives; and 3) based on the informant's responses to the general screening questions, a Face Sheet and one or more of five symptom checklists (depression, mania, alcohol and other drug abuse, psychosis, paranoid/schizoid/schizotypal personality disorder) are completed for each first-degree relative, spouse, or other relative well known to the informant. A particular symptom checklist is completed if, based on the informant's responses to the general screening questions, the interviewer suspects that the psychopathology assessed by the particular symptom checklist is present.
The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) is a semi-structured interview for making the major DSM-IV Axis I diagnoses. The SCID Research Version has been expanded to focus on additional features of illness in bipolar and depression and include automated scoring of SCID diagnoses. The SCID-RV can be modified to suit the needs of a particular study.
The Aspect software has been used in cancer clinical trials. A selection of forms from ACRIN Study 6652 were developed in an NCI-funded research grant to demonstrate compatibility with ACRIN’s Clinical Trials Network. ACRIN Study 6652 is the Digital vs. Film Mammography in the Digital Mammographic Screening Trial (DMIST).
The Semi-Structured Assessment for the Genetics of Alcoholism (SSAGA), expressly developed for COGA, is a polydiagnostic psychiatric interview that covers the major psychiatric disorders in DSM-III-R and provides complete diagnoses in DSM-III-R and ICD-10 as well as diagnoses for Substance Dependence in Feighner and DSM-IV.
NIDA-CTN-004 MET to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse. In a NIDA-funded research grant, INFOTECH Soft is developing a set of graphical tools and automated software applications that will help simplify, automate, standardize, and reduce the cost of creating and reporting clinical research instruments used in substance abuse clinical trials. A CRF Generator proof-of-concept demonstrated that automatically generating CRFs for EDC can be completed in significantly less than 10 minutes per CRF with no coding errors, and a Cost Benefit Analysis demonstrated that automatically generating CRFs for EDC can be completed over 3,500 faster and with fewer errors than manual coding methods.