User Guidance

• Pure Substance Requests - VH Pure Substances are available for preclinical research (in vitro or animal) to study novel disease biology and advance scientific knowledge.
• Investigator Sponsored Study - VH provides some form of support (product, funding, expertise*, specialized activities), but another entity is the Sponsor accountable for ALL aspects of the study.
  

  *ISS expertise is limited to benefit/risk expertise related to the VH product in the study.

• Collaborative Study – A study in which VH actively works with a Collaborating Party (CP - an external research organization or institution or another pharmaceutical company) to develop and conduct a research study of mutual scientific and/or clinical interest.

• ViiV support of approved proposals can be in the form of funding and/or study materials (including ViiV products or placebo)
• In exceptional circumstances where the study requires a specialized capability to perform a specific activity (e.g. biomarker research) that the sponsor does not have and cannot feasibly retain an appropriate vendor; ViiV may perform the specific activity as part of ViiV’s support. Any ViiV funding for the study will reflect the fact that ViiV is providing this support.

• Design the protocol
• Develop and maintain the case report forms
• Initiate and monitor the study
• Understand and comply with any and all pertinent laws, regulations, and guidelines
• Understand and comply with any and all requirements of institution(s) with which they are associated or in which research will occur
• Report safety data to regulatory authorities, the IRB/IEC, and ViiV

• Provide approved support as outlined in the legal agreement in a timely manner
• Provide any scientific/medical feedback to the investigator-sponsor at any point in time regarding the proposal, the protocol, or any aspect of study conduct where ViiV has a concern about the scientific integrity of the study or patient well-being

• Everything begins with a discussion with a ViiV Representative about your concept. Once you have registered, you will then be able to submit research concepts/proposals to ViiV
• Throughout this step and all phases of the process, you will be notified about various documentation requirements, such as your curriculum vitae, budget request (if applicable), Financial (if applicable), and Study Milestone updates.
• Once you have submitted a concept, it will be reviewed by ViiV ISS personnel; if there are any questions, you will receive notification from ViiV for clarification or additional information
• You will be notified of ViiV's decision to proceed with a full proposal. If a full proposal is requested you will receive access to a "Submission Form" to complete. The proposal will move into our multi step global ISS proposal review process where ViiV medical personnel will review the proposal and make a decision; this decision could be approved, approved with conditions, declined or a request for additional information.
• If the proposal is approved, the process then moves into protocol and contract development and review. If you submit a full draft protocol with the initial proposal (not required), then the time between approval and contract execution may be shortened.
• Once the protocol is approved, we will then finalize contractual terms of the ViiV support being provided and expectations for you as the study sponsor. The contract with VH will generally require the publication of study results in a timely fashion and that the Sponsoring entity grant ViiV -as a minimum- an indefinite non-exclusive license of all data, information and intellectual property resulting from the Study and an option to negotiate an exclusive license.
• After the contract is finalized and all supporting documentation has been obtained, we will then be ready to start the conduct of the study
• Throughout study conduct, you will be notified for study progress reports and supporting documentation for any support payment, produce shipment requests, etc.
• Once study conduct is complete, we will then move into closing out the study and enter the publications phase of the study (final deliverables from the study as defined in the contract)
• Per the contractual terms, ViiV will request review of any defined deliverables from the study (abstracts, publications, etc.)
• At any point, you will be able to go into your account in the system and see the status of your proposal(s) and/or study(s)

• The first step is to have a discussion with a ViiV representative about your concept.
• Following your discussion, click on the "Create a Submission button".
• You will be required to record your agreement with an Attestation Statement in order to complete and submit your concept. Click the LINK to view a copy of the statement.
• Your concept will then be reviewed and given a decision by ViiV medical personnel for the given product. The decision could be to submit a full proposal, not interested or more information needed.
• If a full proposal is requested, you will receive a Submission Form to complete. This form will consist of Part A and Part B.
• Part A is an online form that basically captures categorical information about your proposal; this information is collected directly in the system to enable the proper internal routing and classification of the proposal.
• Part B of the form captures the detail of the actual study you are proposing, including aspects of the overall study design, target population, statistical analysis plan, etc.
  • (There are two options in completing Part B of the form: You can complete the information on the form or You can select the N/A for each section and submit your own full draft protocol via the "Files" function.
• After completing the form, you can also submit any other needed attachments at this point or later in the process; this could include an itemized budget for funding support requested, your curriculum vitae, or other study related documentation.
• The status of your study will be set to "Proposal Under Development" while all documents are being submitted by you and reviewed for completeness.
• Once all the required documents are received by ViiV, the status will be changed to "Proposal Under Review".

At any time, you can then click on "My Submissions" and check the status of the proposal, add additional attachments to the system, or review correspondence that you have received from ViiV.

• The password should be at least 8 characters
• The password must include at least 1 UPPER case letter (A-Z)
• The password must include at least 1 lower case letter (a-z)
• The password must include at least 1 numeric character (0-9)
• The password must include at least 1 symbol character (e.g. &, #, @)

• A delegate is a person with a ViiV ISR Portal account who has been identified by the Principal Investigator (PI) of a study as someone who should have access to that study. The delegate will have permission to access and provide data on the Investigator’s behalf for the specific study they are assigned to as a delegate.
• All Contacts for a study (Principal Investigator and delegates) will receive system notifications with respect to the study to which they are assigned.

• The Principal Investigator (PI) for the study must first ensure that the delegate has an account in the portal. The delegate may create an account following the steps under "How do I create an Account to log in?"
• Once the PI has confirmed that the account is created, they should complete the Investigator Delegate Request form for each delegate. The completed form can be returned to ops.visions@viivhealthcare.com. (Note: The request form is a fillable PDF form that can be completed, saved and emailed or printed out, completed and then scanned).

• The Principal Investigator (PI) for the study must request in writing (email is acceptable) that the delegate be removed. Emails may be sent to ops.visions@viivhealthcare.com.

• Conduct a high quality ethical study
• Register the protocol on a public web site
• Complete required documentation in a timely manner
• Meet applicable deadlines as defined in the legal agreement
• Report any safety issues and adverse events in a timely fashion as defined in the legal agreement.
  See ViiV ISS Safety Requirements for more information
• Disclose any affiliation or financial conflicts of interest
• Publish study results
• Ask questions whenever needed

• Professional interactions with ViiV employees who put patient needs first in all that they do
• Timely responses to any inquiries or requests coming from the sponsor, including decisions on completed proposals
• An easy to use ISS system
• Compliance with data protection laws with respect to the personally identifiable information of the sponsors/investigators

• Once reviewed for completeness, all proposals go through a multi-step global review process that is made up of key medical, safety, statistics, regulatory, finance and drug supply personnel.
• Decisions are made based primarily on the overall scientific rationale of the proposal; additional considerations include alignment with ViiV’s areas of scientific interest, qualifications of the proposal sponsor, availability of internal funding resources, a fair market value assessment of any funding requested, and evaluation if similar research is already being conducted or has been conducted around the globe

• FDA Forms
• US W-9 tax form
• US W-9 tax form instructions
• Federation of State Medical Boards – Medical Licensure information
• OIG Exclusions Database
• FDA Debarment list
• FSA Disqualification/Totally Restricted List for Clinical Investigators
• PHS Administrative Action Bulletin Board