Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database FAQ

General Questions:

Is there a fee for using this site?
A: There is no fee to use the site.

What data are contained in this data platform?
A: Details related to data content are made available to registered users of the platform. The platform contains placebo arm data from MS clinical trials, which includes data on demographics, medical history, performance outcome measures [e.g. Timed 25 Foot Walk (T25FW), 9-Hole Peg Test (9HPT), Paced Auditory Serial Addition Test (PASAT), Low Contrast Visual Acuity (LCVA)], clinician reported outcome measures [e.g. Expanded Disability Status Scale (EDSS)], patient reported outcome measures [e.g. 36-Item Short Form Health Survey (SF-36)], relapse information, and MS type (e.g. relapsing-remitting).

SDTM DomainData Elements
Clinical Events (CE)All relapse events (severity, duration)
Concomitant Medications (CM)Dexamethasone, Methylprednisolone, Prednisolone, Prednisone
Demographics (DM)Age, Gender, Race, Country
Disposition (DS)Early withdrawal reason and study day
Findings About Medical History (FAMH)Number of relapses before study
Functional Tests (FT)T25FW, 9HPT, PASAT, SDMT
Medical History (MH)MS Diagnosis, MS Type, General medical history
Ophthalmic Examinations (OE)Visual acuity (including LCVA)
Questionnaires (QS)EDSS, FSS, SF-36, SF-12, BDI
Reproductive System Findings (RP)Pregnancy tests
Subject Characteristics (SC)Dominant hand
Subject Disease Milestones (SM)Confirmed relapses
Trial Disease Milestones (TM)Study definition of relapse

How are the data standardized?
A: All data have been remapped to a common data standard (CDISC STDMIG v3.2) to maximize utility of aggregated data for statistical analysis. All data are fully anonymized.

Registration for Access Questions:

How do I register for access to the MSOAC data platform?
A: Visit the Multiple Sclerosis Outcome Assessments Consortium website and click on MS Data Requests. You must first review and agree to the Data Use Agreement/Terms and Conditions for the MSOAC data platform.  Once completed, you will be directed to the online application form, where you will be asked to submit your bio sketch information, and a brief summary of your research plan.

How long will it take for response to my access request?
A: All access applications must be reviewed by the MSOAC Review Board. Requests may take up to 4 weeks to process.

My request for access was denied. Do I have any recourse?
A: Access requests are reviewed by the MSOAC Review Board. The process allows the requester the opportunity to address any issues found during the review. Every attempt is given to provide requesters the opportunity to provide additional information in order to bring their registration submission to a state that meets approval. Reasons for access denial are always communicated to the requester.

Data Contribution Questions:

How and when can I contribute my data to the MSOAC platform?
A: Individuals, organizations, institutions and countries (health ministries, national MS programs, etc.) are encouraged to contribute clinical study data. In addition to the study dataset, submitting organizations will be requested to provide information regarding study methodology and demographic data for their submissions. Please contact Lynn Hudson ( for additional information.

Will I still own the data that I am contributing to the MSOAC data platform?
A: Yes, data ownership is always retained by the data contributor. The data contributor signs a data contribution agreement that allows the contributor to specify the conditions of data use.

What measures are in place to ensure data platform security?
A: MSOAC policies for data transfer, validation, processing and access meet or exceed industry standards. The following features are in place to ensure that the data is safe and secure:

  • Data Contribution Agreement
  • Secure file transfer
  • Operating System hardening and security updates
  • Host-based intrusion detection/prevention system
  • Anti-malware protection
  • Automated log monitoring and alert system
  • Data encryption, de-identification, and anonymization
  • Data access controls for incoming server, investigational database, analysis datasets
  • Data backup and disaster recovery
  • Data provenance – changes to data will be traceable and auditable throughout its lifecycle
  • Multi-factor authentication
  • Multi-tier network structure
  • File integrity monitor

In what format should I contribute my data to the MSOAC effort?
A: The MSOAC platform can handle data in multiple formats. We typica