If the request is approved and a Data Sharing Agreement (DSA) signed, MSD will upload the anonymized data into the Vivli platform for use by researchers in the secure Vivli research environment.
*For more information about the secure research environment sizes, software and no charge period click here.

This platform allows researchers to conduct research on the site and to download their analyses. Researchers are invited to conduct their research in a private secure research environment. To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of anonymized data provided for access.

Primary Approach: The following more restrictive application of the “Safe Harbor” method should be followed when considering the anonymized of datasets (both raw and analysis):
1. Recode subject identifiers, site identifiers, and site locations; remove investigator identifiers.

• Subject Identifiers – Both baseline numbers and allocation /randomization numbers should be randomly assigned new values.

Note: The link (e .g., seed used for random number generation) between the original subject identifiers and the recoded identifiers should be destroyed.

• Site Identifiers – Site numbers should be randomly assigned new values
• Site Locations – Recode specific site locations to corresponding region of world
• Investigator Identifiers – Investigator names and numbers should be removed

2. Remove all verbatim terms and comment fields

• If a verbatim term is deemed critical for analysis purposes and it does not contain identifying information (through review of the contents), it may be included.

3. Replace all dates with relative-day to randomization

• If required, multiple relative-day variables can be created if the important reference date is not randomization.

4. Modify age-related information

• Remove date of birth fields
• For non-pediatric studies, keep age fields in terms of years only (smallest unit allowed) and recode ages >89 years with the text “90 years or older”.
• For pediatric studies, keep age fields in terms of months only (smallest unit allowed)

5. Additional considerations

• Assess any therapeutic area-specific fields that may contain PHI.

Alternative Approach: In the event that certain data restricted by the primary approach must be shared, the “Expert Determination” method described in the OCR guidance document should be used to ensure that the risk of re- identifying the data is very small. The expert (either internal or external to MSD) will apply appropriate statistical /scientific principles and methods to assess the risk of re-identification, and document the methods and results of the analysis that justify the determination.

• MSD may not have legal authority because the product was co-developed with a partner or obtained from an external partner under a contract that does not permit the disclosure.
• It may be difficult to ensure protection of the privacy and confidentiality of research participants. For example, small trials (e.g., with less than 50 participants) or studies of rare diseases may have too few participants to prevent re-identification of individuals.
• The informed consent or local regulations may not allow for data sharing.
• There may be substantial practical constraints to providing access to the data (for example, size and complexity of databases or resources required to retrieve data from repositories and redact personally identifiable information from relevant documents).

• Conflict of interest will be assessed; data will not be released to individuals with significant conflict of interest or individuals requesting data access for competitive, commercial or legal interests.
• Funding requests are not supported under this procedure.

Review Criteria:

• Does the proposal include a clearly defined research question and scientific rationale, and is the proposed research relevant to medical science or patient care?
• Is there a well-documented statistical analysis plan?
• For correlative biomarker research, is there a clearly specified and biologically novel hypothesis?
• Is there an ability of the proposed research plan (design, methods and analysis, statistical power) to meet the scientific objectives?
• Is there an adequate publication plan for disseminating the research?
• Is the research applicant willing to disclose any real or potential conflicts of interest that may impact the planning, conduct, or interpretation of the research?
• Does the research team have the expertise, qualifications and experience to conduct the proposed research (e.g., does it include a biostatistician as part of the research team)?

The following basic information will be required:

1.  Detailed Research proposal which includes:
   1. Background and rationale
   2. Objectives of the research
   3. Scientific Hypothesis
   4. Statistical analysis plan
   5. Publication plan
2. Curricula Vitae of all researchers including the biostatistician

Data Sharing Agreement

Before access to clinical trial data is provided, the researcher must enter into a standard data sharing agreement with MSD. The data sharing agreement commits the researcher to use the data only for the stated research purpose and to not disclose the data to third parties. This is in line with data privacy legislation. In addition, researchers are expected to commit to transparency in the publication of their work.

Completed applications will be reviewed by MSD with input as needed from an External Scientific Review Board (ESRB) comprised of non-MSD scientists or physicians. Researchers will receive an acknowledgement of receipt, and the request will be evaluated by an internal MSD review committee comprised of subject matter experts in the relevant therapeutic area.

After the request is assessed for feasibility, the MSD review committee will assess the scientific validity of the request and the qualifications of the requesters. If the MSD review committee determines that the request is scientifically valid and the requesters have the appropriate expertise to perform the proposed analysis, then the request will be approved, and data will be shared.

If there are questions or concerns regarding the scientific validity of a data request from the MSD review committee, the request will be forwarded to the ESRB for further review. Additional details on the governance of the board can be found in the External Scientific Review Board Charter

A recommendation from the ESRB will be communicated to the MSD Steering Committee, which is comprised of the research heads of clinical, regulatory, and biostatistics. The MSD Steering Committee will make the final decision on the data request after consideration of the recommendation from the ESRB.

MSD will communicate a formal notification of the status and the rationale to the researcher.

Individual Patient Data – IPD ACCESS:
MSD will provide researchers with access to anonymized participant-level data needed to address the specific research question consistent with the requirements.
If a request for a full CSR is approved, MSD will provide researchers with the CSR in a redacted form that is consistent with the need to protect participant privacy and confidential commercial information.
* Protocol/Statistical Analysis Plan are available on the ClinicalTrials.gov public registry for completed trials that have results published and can be accessed via the NIH website.