Clinical Research eCRF Specifications

Clinical Research eCRF Specifications

Parties and Project Identification

Client Name:

Vendor Name:

Study Title:

Protocol Number:    Study Phase:

Recitals

WHEREAS, Client is the sponsor of the clinical study identified above and requires design, development and delivery of an electronic Case Report Form (eCRF) system and associated deliverables for collection of study data in accordance with the protocol; and

WHEREAS, Vendor represents that it has the expertise, personnel and technical capability to design, configure, validate and deploy the eCRF and related services identified in this Specification; and

WHEREAS, the parties agree that the specific features, data elements, acceptance criteria, and delivery milestones for the eCRF are set forth in this Clinical Research eCRF Specifications document and will form part of the binding agreement between the parties.

Scope of Work

Deliverables include: eCRF design documents, data dictionary, edit checks, programmed eCRF, test scripts, validation deliverables, deployment to designated environment, user training materials and post-deployment support. Specific deliverable details and acceptance criteria are set forth below.

Data Elements, Standards and Validation

Data Dictionary Version:    Coding Conventions:

Edit checks, derivations and calculated fields will be specified in the final data specification deliverable. Vendor shall implement automated edit checks described in the data specification and shall provide test evidence demonstrating that each edit check functions as specified.

Delivery Milestones and Schedule

Target Completion Date: Month Day Year

Target Completion Date: Month Day Year

Payment Terms

Total Fee: $

Late Payment Fee:    Invoicing Terms:

Term and Termination

Term Start Date: Month Day Year

Term End Date (if applicable): Month Day Year

Termination for Convenience: Either party may terminate upon written notice of days. Termination for Cause: immediate for material breach if not cured within days following notice.

Confidentiality and Data Protection

Vendor shall treat all Client data, study materials, and any non-public information disclosed in connection with this Agreement as Confidential Information. Confidential Information shall not be used except for performance of Vendor's obligations and shall not be disclosed to third parties except as required by law or with prior written consent of Client.

Data Ownership: All study data collected in the eCRF and any derivative data are owned exclusively by Client. Vendor will not assert any ownership or other rights in Client data. Vendor shall return or securely destroy all Confidential Information and Client data within days of termination, except as otherwise required to comply with applicable law or retained for archival regulatory purposes.

Security Controls: Vendor shall maintain administrative, technical and physical safeguards appropriate to the sensitivity of the data, including access controls, secure transmission, and audit trails documenting all create/read/update/delete events.

Validation, Testing and Change Control

Vendor shall provide validation deliverables demonstrating that the eCRF functions in accordance with the data specification and acceptance criteria. Vendor will support User Acceptance Testing (UAT) and provide defect tracking until acceptance. Approved change requests will be implemented under the change control process and documented with versioning.

Warranties, Liability and Indemnity

Vendor warrants that the eCRF will substantially conform to the specifications on acceptance. Except as expressly set forth, Vendor disclaims all other warranties, express or implied. Each party's liability for direct damages shall be limited to the fees paid under this Specification for the affected study. Neither party shall be liable for indirect, incidental or consequential damages. Vendor shall indemnify Client against third-party claims arising from Vendor's breach of confidentiality or willful misconduct.

Governing Law and Entire Agreement

Governing Law: This Specification shall be governed by the laws of without regard to conflict of law principles.

Entire Agreement: This Specification, together with any executed master agreement between the parties, constitutes the entire agreement with respect to the subject matter herein and supersedes all prior proposals, understandings and agreements, whether written or oral.

Change Requests and Notices

Change requests shall be documented, priced and submitted for written approval. Notices required by this Specification shall be sent to the contact persons designated by the parties below:

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