Existing Customer? Are you an existing Cogstate customer? * Name of existing study * Name of Principal Investigator * DataPoint URL Site (If applicable) Is the new study replicating or building on a study previously using Cogstate? * 21 CFR Part 11 Compliance
If the data from your study is intended to be included in a US Food and Drug Administration (FDA) submission for the approval of a medication or medical device, then your study meets the criteria for 21 Code of Federal Regulation (CFR) Part 11 Compliance.
Please note, this also applies to FDA approved drugs being investigated as potential new treatments for unapproved or off-label indications.
Part 11, Electronic Records; Electronic Signatures - Scope and Application | FDA Will the data generated from this study be submitted to the FDA or other regulatory agency as part of a drug or device approval process requiring 21 CFR Part 11 Compliance? * Study Details Full Study Title * Short Study Name *
The name of your study must be 2-16 characters long containing only Alpha and Numeric characters and dashes. Please note that no spaces are allowed between the characters.
Testing Environment How will you be administering the battery? * In-Clinic supervised Remote supervised Remote unsupervised In-Clinic supervised Supervised (at-site) assessment available with automated analysis and reporting. Remote supervised Participants test at-home or other ‘non-traditional’ location, but test administration is still overseen (via telephone, video call, or visiting nurse). Remote unsupervised Participants test independently at-home or other ‘non-traditional’ location using tests specially designed for autonomous administration. Hardware specifications * PC iPad Tablet
The standard Cogstate Research product is designed for PC and is compatible with Windows XP, Vista, 7, 8, and 10 operating systems. PCs used for testing should have at least 10 GB hard disk drive (HDD), 1024 MB RAM, USB port, sound capability and a display with 1024 x 768 minimum resolution. No interfering software or browsers should be running during testing, and an internet connection is required for data uploading (or USB sticks can be used to transfer data to an internet connected computer for upload).
Participants Participants will include members of the following age ranges * 4-5 6-9 10+ Indicate the population group * Healthy Patient Group Expected Number of Subjects * What is the main area of interest for the study? * Please select Alzheimer's Disorder/Mild Cognitive Impairment Amyotrophic lateral sclerosis (ALS) Anxiety disorders Autism Bipolar and related disorders Chronic Pain Concussion/Traumatic Brain Injury Depressive disorders Diabetes Disruptive, impulse-control, and conduct disorders Dissociative disorders Eating disorders Epilepsy General Cognition HIV Multiple Sclerosis Oncology Parkinson's Disease Personality disorders Schizophrenia spectrum Sickle cell disease Sleep-wake disorders Substance-related and addictive disorders Trauma-/stressor-related disorders Other
Select a category that best describes the general area of interest in the study.
Describe the specific indication/condition *
Describe the specific disease of interest in the study (i.e. Refractory Lymphoblastic Leukemia or Treatment-Resistant Major Depressive Disorder).
Testing Languages * Afrikaans (South Africa) Danish (Denmark) Dutch (Belgium) Dutch (Netherlands) English (Australia) English (Canada) English (India) English (Israel) English (Malaysia) English (Puerto Rico) English (South Africa) English (United Kingdom) English (United States) Finnish (Finland) French (Belgium) French (France) French (Switzerland) German (Austria) German (Belgium) German (Germany) Greek (Greece) Hungarian (Hungary) Italian (Italy) Japanese (Japan) Korean (Korea) Lithuanian (Lithuania) Polish (Poland) Portuguese (Brazil) Portuguese (Portugal) Romanian (Romania) Russian (Russia) Russian (Ukraine) Simplified Chinese (China) Spanish (Argentina) Spanish (Chile) Spanish (Colombia) Spanish (Mexico) Spanish (Peru) Spanish (Puerto Rico) Spanish (Spain) Swedish (Sweden) Traditional Chinese (Taiwan) Urdu (India) Other
Select multiple languages if applicable
Additional language *
Additional languages can be added at an additional fee. Please list any additional languages needed.
Study Design Start Date * End Date * What cognitive domains are you interested in measuring? * Associative Memory Attention Emotional Cognition Executive Function Memory Motor Function Paired Associate Learning Processing Speed Psychomotor Function Recognition Memory Spatial Working Memory Sustained Attention Verbal Learning Verbal Memory Vigilance and Sustained Attention Visual Learning Visual Memory Visual Motor Control Working Memory Cogstate Testing Sessions (estimated visit schedule) *
Describe the schedule of evaluations where cognitive testing will be conducted (i.e screening, baseline/enrollment, weekly treatment visits at weeks 1-10).
Is this study a drug intervention study? * Is it a natural history study? * Does your study need any additional support? (select multiple if needed) General items Data Cleaning Hardware Provision of Data Transfers Scientific Consulting on Battery Design Scientific Consulting on Data Analysis Data Cleaning / Data Monitoring / Provision of Data Transfers Secure online portal, DataPoint®, enables efficient data collection and storage for ongoing review of data quality by our expert data management team. Hardware Manage the distribution of hardware and supplemental materials, such as manipulatives and instruction manuals, to sites. Project Management Dedicated project managers to efficiently drive all study activities from kick-off to final report delivery. Scientific Consulting on Battery Design / Scientific Consulting on Data Analysis Custom batteries with expert input based on your objectives, study design and population. Statistical Analysis Full data analysis delivered as a set of tables - word document Full data analysis delivered as a slide set Scientific consultation in support of final data interpretation of Cogstate results Summary statistics of performance outcomes displayed in a slide set
Our statisticians and cognitive experts customize analysis plans with careful consideration of the study objectives, design and execution.
Training & Certification Access to Cogstate’s online training system for training & certification of all Test Supervisors Telephone & Online training sessions for Test Supervisors
Online site training and certification enables high-quality assessments by non-expert staff and full support from the development of regulatory submissions that involve cognition to preparation and attendance at meetings with regulatory authorities
Additional Information Please provide a summary of the study and any other relevant information *
Additional tests can be provided at an additional fee via Custom Software Configuration.
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