Neurology

Study design

Eligibility criteria definition

Primary end point definition

Sample size

Timetables

Scheduling of assessments and visits

Site review and selection

Model consent forms

Safety and efficacy monitoring

Detailed operations manuals

SOP development

Pharmacoeconomic Outcomes

Quality-of-Life Measurement

Content development

Efficient data entry design

Case report forms production

Packaging and distribution to sites

Computer application to track forms received

Tracking of forms in the database

Development of relational database structure

Capabilities for electronic transfer of data

Hard copy transfer of research study site data

Monitoring of keypunch format and range validations

Error identification and correction processes

On-site monitoring of facilities, case report forms and source documentation, including reviews of: adequacy of patient and study facilities; drug dispensing, accountability, and storage; protocol, case report forms, laboratory procedures, adverse event reports, medical record (source) documentation, informed consents, and study file.

Case review by medical staff

Guidance by safety monitoring committee

Establishment of subcontracts with principal investigators and their participating research sites

Compliance with ICH, federal and pharmaceutical regulatory requirements and guidelines

Fiscal management of grant contractual and subcontractual agreements

Development and administration of research study budgets

Coordination of investigator/coordinator and steering committee meetings

Management of multi-center investigator groups

Preparation of manuscripts for peer-reviewed publication

Preparation of regulatory reports

Consultation on protocol design/end point selection/analysis

Basic study design

Sample size/power calculation

Randomization plan

Primary/secondary outcome variables

Establishment of stopping guidelines for safety monitoring

Management, maintenance, and quality control of analytic database

Data management for study drug compliance and other blinded data

Data analysis and reporting

Unit-dose packaging

Labeling or re-labeling of drug to maintain blind testingedness

Protocol-specific computerized drug inventory and shipping schedules for research study sites

Quality control

Cerebrospinal Fluid

DNA

Tissue

Video

Parkinson’s Disease

Huntington’s Disease

Human Immunodeficiency Virus

Tourette’s Syndrome

Attention Deficit Disorder

Epilepsy

Cervical Dystonia