1. General
1.1 The Agreement consists of the Agreement and the TCs and constitute the entire and only contractual relations between the parties relating to the Project and the tasks, and all prior negotiations, representations, agreements, and understandings are superseded hereby.
1.2 In case of any conflicts between the Agreement and the TCs, the Agreement shall prevail.
1.3 All terms that are related to the divisions involved in the Project as set forth in the Agreement ("Tasks") are applicable.
2. Obligations /Aims
2.1 DCR agrees to use its good faith efforts to conduct its tasks within the Project as set forth in the Agreement ("Tasks") signed by both parties as an independent contractor, in accordance with DCR Quality policy, applicable laws and regulations, and the protocol, in its current version and as provided for by Partner, if applicable. If appropriate, Partner assumes all obligations as the sponsor of the Project according to the current versions of the Swiss Human Research Act of 30. September 2011 and related ordinances and according to applicable laws and regulations.
2.2 Partner agrees to support DCR in order to conduct the Tasks within the Project by paying a contribution according to Article 3 as well as providing all necessary data and information required to perform the Tasks.
2.3 For the sake of clarity, DCR shall only perform the Tasks as set out in the Agreement and have no obligation to perform further work except additional specification of activities and their remuneration agreed upon written amendment to the Agreement. Specifically, any additional expenses incurred by DCR in the course of inspections or audits are not covered by this Agreement and will be additionally reimbursed to DCR by Partner, unless such expenses are explicitly covered by the agreed cost estimate.
3. Contribution
As support for performing the Tasks within the Project, DCR shall be paid in accordance with the agreed costing. Costs will be invoiced in CHF and for costs outlined in the agreement, or actual working hours performed which may deviate from the estimate of required hours made in the costing. Any transfer fees shall be paid by the invoice recipient. Without prejudice to the aforesaid, each party shall bear its own costs, arising in the conduct of the Project.
4. Term
4.1 The term of this Agreement shall begin on the date of signature of the Agreement by DCR and representative of the University of Bern (if the agreement exceeds 50’000 CHF) and shall continue until all responsibilities are completed.
4.2 DCR and/or Partner may terminate the Agreement at any time for justified reasons such as untoward side effects or other medical risks occurring during the Project, or an ineffective working relationship between DCR and Partner.
4.3 In the event of the termination of the Agreement, costs for any work completed will be required to be paid by the Partner. Additional applicable costs payable by Partner may include Project closure and archiving activities, and salary costs for staff whose contracts are terminated due to the Agreement termination.
4.4 A party may terminate the Agreement immediately if the other party breaches or is in default of any obligation agreed upon in the Agreement or of the included TCs of DCR and which has not been cured within thirty (30) days after receiving written notice of such breach or default.
4.5 Partner shall provide DCR with all information and documents required for DCR to perform its agreed Tasks within the Project. This may include, but is not limited to:
- ethics committee and regulatory authority approval (unless services provided by DCR were completed prior to ethics committee or regulatory authority approval),
- first study participant enrolled,
- recruitment stopped prematurely or temporarily interrupted,
- last study participant visit performed,
- data cleaning completed,
- any new protocol version implemented during the course of the Project,
- changes in study staff requiring access to the clinical data management system.
4.6 DCR reserves the right to replace or shut down any involved IT systems, e.g., clinical data management systems, whenever it is justified according to DCR, for example for IT security or study participant security. DCR will inform all parties involved 6 months ahead of the replacement or shut down. All costs relating to a potential migration of the data or database to a different IT system, e.g., clinical data management system, must be borne by Partner.
4.7 DCR reserves the right to update the clinical data management systems at any time, which may lead to a few downtimes a year. During the specified time, the clinical data management system is not available (including randomization, surveys, or any other functionality).
4.8 DCR is committed to providing services in due time to meet anticipated project timelines. To allow appropriate planning, Partner is asked to inform DCR in good time about the anticipated date/time frame of the contracted services. DCR will advise Partner of any delays or inability to deliver contracted services.
4.9 DCR is available for support and requests during normal office hours (Monday to Friday from 9-17h, best via email). DCR does not offer services during nighttime, weekends, or public holidays.
4.10 Partner acknowledges all terms listed in Appendix I related to data management and clinical data management systems (so-called Full Service or REDCap Light).
5. Liability
Partner shall indemnify and hold harmless DCR, its regents, officers, agents, and employees from any and all liabilities, losses, damages, claims, and expenses in connection with any claim or lawsuit brought against DCR by a third party as a result of i) the performance of the Tasks as set out in the Agreement by DCR, ii) from the use by Partner of the results of the Project, or iii) from a possible misuse of the local super user rights provided to Partner on the study database (e.g., in case data/database needs to be corrected/restored due to misconduct by Partner, all costs have to be borne by Partner), provided, however, that Partner shall not hold DCR harmless from liability resulting from willful misconduct or gross negligence of DCR, its regents, officers, agents, or employees. Furthermore, Partner shall have a recourse claim against DCR for the cover of damage resulting from willful misconduct or gross negligence of DCR, its regents, officers, agents, or employees.
6. Warranties
6.1 DCR agrees to properly perform, to the best of its knowledge and taking into account the current state of the art, the Tasks assumed by it under this Agreement.
6.2 DCR makes no warranties, expressed or implied, as to any matter whatsoever, including and without limitation, the accuracy of the results of the Tasks or any invention(s) or product(s), whether tangible or intangible, conceived, discovered, or developed under this Agreement; or the merchantability, or the fitness for a particular purpose of the results of the Tasks or for any such invention or product.
7. Intellectual property
7.1 Partner shall retain full ownership of the results arising from performing work governed by the Agreement, provided, however, that DCR shall be entitled to use the results for internal and non-commercial purposes.
7.2 All know-how, processes, procedures, methods, and developments including but not limited to scripts provided for the use of data preparation, validation, and analysis, which are solely developed and used by DCR to perform the Tasks and all intellectual property related thereto, whether created before, during, or after the Project, shall be owned solely by DCR, (hereinafter "Know-how"), and, if made available to Partner, Partner agrees to acknowledge the use of Know-how or consider co-authorship in any publication Know-how is used for (altered or unaltered). (Refer to Appendix II for further details on DCR’s Authorship Guidelines).
7.3 Partner agrees and acknowledges that DCR may collaborate with and uses software/database solutions of Webspirit Systems GmbH, Böttgerstrasse 2/3, D-89231 Neu-Ulm in the performance of the tasks hereunder.
8. Publication and confidentiality
8.1 Partner shall have the right, consistent with internationally accepted academic standards, to present and publish results of the work governed by the Agreement. Authorship will be governed by the Uniform Requirements issued by the International Committee of Medical Editors (ICMJE). (Refer to Appendix II for further details on DCR’s Authorship Guidelines).
8.2 Each party shall hold in confidence for three (3) years after the termination of the Agreement any confidential information identified as confidential and obtained from the other party during the course of this Project (hereinafter “Confidential Information”). Nothing herein, however, shall prevent the parties from using any information generated hereunder for ordinary research and educational purposes. Confidential Information may be disclosed to the extent required by information-, data protection-, and archive legislation, and for purposes of study participant care.
8.3 The parties agree that DCR's use and disclosure of study participant health and medical information is subject to compliance with applicable state and federal data privacy laws. The parties, therefore, agree to take all reasonable steps to protect the confidentiality of any study participant health and medical information that they have access to and to comply with applicable laws.
8.4 Partner acknowledges that DCR aims at being independent of financially driven biases and therefore maintains a funding list on DCR's website, where the Project will be included, if relevant.
8.5 All works such as templates, work instructions, and user manuals that are created and authored by DCR are under the Creative Commons Attribution 4.0 International License. The Partner may reproduce, distribute and make publicly accessible the work. Partner must include the name of DCR, the title of the work, its sources, and this license CC-BY 4.0. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
9. Governing law and Place of Jurisdiction
The Agreement and these TCs of DCR shall be governed by the laws of Switzerland. Place of jurisdiction shall be Bern, Switzerland.
Appendix I: Terms related to data management and clinical data management system (CDMS)
A Terms for so-called Full Service projects (DCRsets up study database)::
- Partner shall approve final eCRFs/database to confirm that DCR has implemented the study database according to Partner’s specifications and to be in line with approved protocol version before database is released for data entry.
- Partner is fully responsible for paying license costs for standardized, validated questionnaires/patient-reported outcome measures/scores as applicable.
- Partner acknowledges that DCR only releases complete and final databases (i.e., no two step release of eligibility/randomization ahead of following eCRFs).
- Partner is informed that DCR takes over responsibility of protocol alignment at the time of the first release of the database. For any further amendments to the protocol or other relevant documents, the responsibility of protocol and eCRF/database alignment lies with Partner.
- Partner is responsible for submitting any eCRF/database changes to the appropriate authorities.
- Partner acknowledges that DCR staff (e.g., monitors, statisticians, clinical study managers) can receive access to the database if needed to fulfill the duties assigned to them by DCR.
- In case a database set up by DCR needs to be modified after a software update in order to ensure correct operation, the costs caused will be charged to Partner.
- In case of a data import by DCR, Partner is responsible for providing correct, complete, and consistent data. If imported data needs to be corrected due to incorrectness, incompleteness, or inconsistencies, the costs caused will be charged to Partner.
- Partner is informed that DCR generally does not charge any license costs or server fees. If a study is conducted according to protocol or as agreed on in regular communication between Partner and DCR, no fees will be applied. Nonetheless, DCR reserves the right to check the activity within a database. In case of no user activity within the past 12 months, DCR will contact Partner and may start charging a fee (and if applicable require an updated contract amendment). The fee of the amount of CHF 1600 will cover the database server costs for the following 4 years.
- After the final DB lock, DCR will provide Partner with data and metadata. Upon receival, Partner is responsible for keeping data and metadata for the appropriate amount of time of the archiving period. The database will be deleted 2 years after extracting the final data by DCR.
B Terms for so-called REDCap Light projects (Partner sets up own study database):
- DCR creates a REDCap project and provides template eCRFs, standard roles, user manual, training slides. DCR is responsible for creating users. Partner is responsible for own study database, including setup of eCRFs/database, testing thereof and deployment; training; user and role management; any changes to the eCRFs/database; closing, locking, and archiving (i.e., Partner is responsible for requesting full audit trail export from DCR); appropriate documentation.
- Partner is requested to inform DCR in case a REDCap super user changes or leaves.
- Partner acknowledges that CTU does not recommend REDCap Light for the following scenarios: (i) blinded studies; (ii) studies exceeding the limit of 15'000 records; (iii) studies exceeding the limit of 5'000 fields.
- Partner acknowledges that DCR does not recommend REDCap Light for the following scenarios: (i) blinded studies; (ii) studies exceeding the limit of 15'000 records; (iii) studies exceeding the limit of 5'000 fields.
- Partner acknowledges that it is their responsibility to validate the database and its functionalities when migrating their projects from another system or from another REDCap installation (i.e., functionality loss while importing projects, e.g., via xml files, relies at the risk or Partner).
- Partner is responsible for paying all fees and licensing costs associated with the use of stand-ardized, validated questionnaires, patient-reported outcome measures, and scores as applica-ble.
- DCR takes no responsibility for performance issues and reserves the right to close down a project if it blocks the system or services.
- DCR, apart from a requested and agreed review before the first deployment, does not review the database for any further deployments, if not specifically requested before the “change to production” request comes in. Requests which are classified by the REDCap system as being “not critical”, will automatically be deployed once the superuser releases the production draft mode changes.
- Partner is responsible for ensuring that the Project specific functionalities (e.g., branching logics, calculations) are still working correctly after a software update.
- Partner is informed that DCR does not charge any license costs or server fees for the first 8 years after creation of the database. After the first 8 years, Partner has the possibility to either get in contact with DCR and prolong the database for the next 4 years for the service costs of CHF 1600 (and if applicable an updated contract amendment), or DCR will take the liberty to set the project status to “complete” after 3 months after being contacted. Partner is informed that DCR will delete the database 2 years after setting status to “complete”.
- This service is only provided for members of the Inselspital Bern or University of Bern. If Partner changes the sponsor’s institution, Partner is requested to find a successor or to move the database. Alternatively, DCR may decide to convert the project to a so-called Full Service, its decision is entirely at DCR.
- In case Partner uploads documents into one of DCR’s CDMS: 1) Documents must be coded (if not approved differently by the ethics committee); 2) the maximum file size is 20 MB; 3) Partner is responsible for overseeing used storage (if not agreed otherwise).
- Partner is responsible for all data presented in their project’s public REDCap report & dashboard section.
Appendix II: DCR Authorship Guidelines
A. Introduction
The guidelines below set out how authorship on publications is managed when DCR supports a Partner in running a clinical study. Authorship is considered on a project-by-project basis and is linked to relevant contributions from the DCR side. Because authorship is important for academic careers, we aim for transparent decisions and are open to discussion where needed.
- DCR shall follow internationally recognized International Committee of Medical Journal Editors (ICMJE) authorship criteria. To qualify as an author, a DCR contributor must meet all four of the following conditions:
- Substantial contribution to study design, data acquisition, or analysis/interpretation.
- Drafting or critically revising the manuscript.
- Final approval of the version to be published.
- Accountability for the work’s integrity.
- If these criteria are not met, contributors should be acknowledged in the acknowledgements section of a respective publication. Similar rules apply for supporting grant applications, where DCR staff may be listed as official applicants or project partners depending on contribution.
B. Role-based Expectations
| Role |
Authorship eligibility |
Typical contributions |
| Statisticians |
Often eligible |
Study design, analysis, manuscript sec-tions |
| Trial Manager |
Often eligible |
Study conduct, revision, project leader-ship |
| Data Manager |
Eligible if contributing to manuscript |
Data plans, quality assurance, text con-tribution |
| IT / Database Developer |
Eligible if contributing to manuscript |
Database design, documentation |
| Study Nurse |
Rare |
Recruitment, data entry |
| QC/Monitoring |
Rare |
Data verification, regulatory checks |
| PPI Administrator |
Eligible if contributing to manuscript |
Coordination of patient/public involve-ment, contributing text |
| Medical Data Science Unit |
Often eligible |
Data science input, methods develop-ment, manuscript text |
| DCR Senior Leadership Team |
Often eligible |
Conceptual leadership, design, supervi-sion, critical manuscript revision |
| Actual Patients and Public |
Eligible if involved in manuscript |
Input into study design, interpretation, drafting of lay sections |
| Other substantial contributors |
Eligible if substantially involved in study design/analysis and manuscript |
Case-by-case |
C. Examples
- A trial manager who coordinates study conduct and revises major manuscript sections quali-fies as an author.
- A data manager who only prepares datasets but does not contribute to the manuscript does not qualify as an author but should be acknowledged.
Appendix III: DCR Courses
1. Course enrollment is subject to the alignment of a registrant’s profile with the course design and intended audience. If a registrant’s profile is determined not to be aligned with the intended course audience, however, payment will be returned to the registrant.
2. Registrations must be submitted no later than 1 month prior to the start date of the course. Course registrations will be closed 1 month prior to the course start date.
3.Each planned course has a minimum and maximum number of participants, which vary depending on the course. Registrants will be accepted in order of receipt of registration.
4.Registrations received after registration acceptance is closed or once the maximum course enroll-ment volume has been reached can be placed on a course waitlist, if the registrant requests this be done.
5.Payment is due when registering for a course. Payment by invoice will incur a 5 CHF processing fee. If the course fee is not paid before it begins, an invoice will be issued which includes an admin-istration fee of CHF 10. Late payments are also subject to additional charges.
6. DCR may cancel or postpone a course if the minimum number of required participants is not met. In the event of cancellation, DCR will inform enrolled participants once the registration deadline has passed and refund any payments received. DCR has no further liability. Enrollment remains if the course is postponed and is carried over to a new date.
7. An enrolled course participant may cancel their enrollment and receive a refund of any paid course fees, minus a course cancellation fee, by emailing education.dcr@unibe.ch no later than 25 busi-ness days before the start of a course.
For enrollments cancelled by the participant less than 25 days before the start of a course, regis-trants are eligible for a 50% refund of course fees minus the course cancellation fee.
DCR Education may consider extenuating circumstances in cases of cancelled registrations within 25 days of course starting date, minus the course cancellation fee.
Course Cancellation Fees
| Course |
Cancellation Fee |
| Clinical Trials in Action for Clinicians, Defining Clinical Re-search Endpoints and Outcomes, GCP I, GCP II, GCP Re-fresher, Models of Contemporary Excellence in Clinical Re-search, PPI for Clinicians, REDCap, Study Nurse Course, Real-World Evidence |
CHF 50 |
| Medical Grant Writing for Clinicians |
CHF 500 |
| Protocol Writing for Clinicians, Quality Management, Statistics for Clinicians |
CHF 250 |
8. Registrants can postpone their enrollment in a course once by emailing education.dcr@unibe.ch before the course enrollment deadline.
If enrollment is postponed after the course enrollment deadline, the registrant will be charged a CHF 50 postponement fee. DCR Education may consider extenuating circumstances in cases of post-poned registrations after the course enrollment deadline.
9. The course exam will be accessible to participants up to two weeks after the course ends. The course content will also be available for up to six months after the course ends. If justified, DCR Education will take extenuating circumstances into account to extend access to the exam by two weeks.
10. A course certificate will be available for the participants who successfully complete a DCR course. If the participant fails the course exam more than 3 times, they will be required to retake the course.
11. Course certificates will be available up to six months after the course ends. After this period, a CHF 10 administration fee will be applied for all requests.
12. Course attestation only occurs when participants attend 100% of the course activities and events and fulfill course work and assessment requirements. These can be obtained by contacting DCR Education (education.dcr.@unibe.ch).
Appendix IV: Insel-Klinik Projects (Insel clinic as partner)
- If clinical services are provided by the CIU to an Insel-Klinik as part of a Project (Insel IIT or exter-nally sponsored), the CIU study nurses become part of the study team of the Insel-Klinik. The prin-cipal investigator of the Project then becomes responsible for the selection and supervision of the study nurses during the Project.
- The CIU undertakes to carry out the tasks it has assumed under the Agreement to the best of its knowledge, taking into account the applicable laws, the guidelines of "Good Clinical Practice" and the requirements of the Insel-Klinik.
- The Insel-Klinik undertakes to assist the CIU in the performance of the agreed tasks within the scope of the services by performing its responsibilities and providing the data and information nec-essary for the performance of the tasks.
Appendix V: Projects involving PPI
- DCR will provide the Partner with a list of PPI contributors who have agreed to participate in the study, however, DCR does not guarantee the participation of these contributors.
- DCR will attempt to replace PPI contributors who have not commenced or have stopped their in-volvement in the Partner’s study, but this also cannot be guaranteed.
- During the grant preparatory phase or once the study commences, the Partner is responsible for managing issues or problems that arise with or between PPI contributors due to their involvement in the PPI panel activities.
- The Partner must be respectful of PPI panel contributors and provide an inclusive environment.
- Unless extenuating circumstances are present, Partner must make use of the contributors pro-vided by DCR.
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