C-SSRS licensing process
eResearch Technology, Inc., a Clario company (“Clario”) has entered into an exclusive license agreement for the electronic implementations of this scale with the Research Foundation for Mental Hygiene, Inc. (RFMH) who controls the copyright for the scale. Over the past several years, Clario has worked with RFMH and the scale authors to optimize the electronic administration of the scale. In order to facilitate broad electronic use of the scale, Clario has developed a sublicensing program that enables other organizations to deploy this assessment as part of their solutions. As part of the program, Clario will ensure a valid implementation of the scale and will collect fees related to its use. Clario will ensure that RFMH is properly compensated for their intellectual property.
Step 1 – License agreement: Download and complete the License Agreement below. You then execute the License Agreement, return it to Clario, and pay the related fees.
Step 2 – Certification: In order to maintain the integrity of the scale, you will need to submit your implementation of the scale for approval. Clario will provide sub-licensee a Reference Specification for electronic implementation of the C-SSRS. Certification is required for each electronic C-SSRS version, language, platform, and combination thereof. Once certification has been granted, the implementation can be used across projects as long as it is unmodified.
Step 3 – Deployment reporting: You will submit a Project Notification Form for each project in which you will deploy the scale. That form will include your information and high level information about the project in order for Clario to track each unique project. Scale administration fees (per administration) and translations fees (as applicable) are invoiced upon receipt of each Project Notification Form. You will not be asked for the name of the project sponsor as part of that process.
C-SSRS certification process
In order to maintain the integrity of the scale, you will need to submit your implementation of the scale for approval before you will be permitted to deploy it. The scale certification process applies where you as the sub-licensee develop your own implementation of a faithful reproduction of the electronic C-SSRS scale.
Under this program, Clario takes responsibility to make sure that the certification process occurs according to the requirements of the developer (Dr. Posner) and that the sub-licensees create and deploy faithful reproductions of the C-SSRS text, formatting, scoring, and logical flow. It will be the sub-licensees’ responsibility to specify, develop, and test their implementation of the electronic C-SSRS in accordance with the requirements document provided by Clario. The Sub-Licensee will submit screenshots of the implementation to RFMH for review in US English. The screenshots should be emailed in a screen report document to Dr. Kelly Posner ([email protected]), copying [email protected]. Dr. Posner’s team will review and approve the specification and implementation within 25-30 BDs. Each time an implementation is re-certified, a certification fee will be assessed.
The Sub-Licensee must address any issues raised by RFMH relating to the implementation’s content, layout, or formatting. Clario will not verify technological aspects of the reproductions, as this would require the Sub-Licensee to submit proprietary intellectual property to Clario. Clario can support the communication with Dr. Posner and RFMH.
The Sub-Licensee will provide the following materials in order as presented:
- Specification document, specific to sub-licensee’s platform, that outlines logical flow of the electronic C-SSRS (English and applicable to all translation implementations)
- Document containing all electronic C-SSRS screenshots captured from implementation of final recording script (English)
The Sub-Licensee may only administer the implemented CSSRS content to trial participants once they have received a written notification from RFMH documenting the certification of the implementation (such notice is referred to as a “Certification”). Licensee may not alter a certified implementation without Clario’s prior written approval.
C-SSRS fee structure
- Administration Fees
- One Time Start-up Fee: $40,000
- Annual Support Fee: $7,500
- Certification Fee: $5,000 per English certification
- License Fees
- C-SSRS (electronic ClinRo): $3 per administration
- Terms
- All fees are paid in advance
- Start-up Fee is payable with your executed License Agreement; upon payment, Clario gives the sub-licensee the “reference spec” for the scale, from which the sub-licensee develops their implementation-specific specification
- Estimated number of scale administrations are pre-paid for each study with underpayment adjusted upon a reconciliation performed at the completion of the project.
- Annual Support Fee due on 1 January each year following the initial contract signature (1st year will be pro-rated depending on initial contract date)
- Certification fee payable with submittal of certification documentation
- If an initiated project is cancelled for whatever reason, the balance of underutilized, prepaid License Fee will be refunded less a $1,000 administrative fee
- Allowable platforms include: Tablet or Web only
- All fees are paid in advance
License agreement
Not ready to sign a license agreement and/or have questions?
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