1. Introduction

DACIMA CLINICAL SUITE IS AN ELECTRONIC DATA CAPTURE (EDC) WEB APPLICATION (HEREAFTER REFERED TO AS “THE SOFTWARE”) DEVELOPMED BY DACIMA SOFTWARE INC. (HEREAFTER REFERRED TO AS DACIMA). PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE USING THE SOFTWARE OR ANY ASSOCIATED MODULES OF THE SOFTWARE. THESE TERMS OF USE (THE “TERMS OF USE”) GOVERN YOUR ACCESS TO AND USE OF THE SOFTWARE. IF YOU DO NOT AGREE TO ALL OF THE TERMS OF USE AND PRIVACY STATEMENT SET FORTH BELOW, YOU WILL NOT BE PERMITTED TO USE THE SOFTWARE. BY ACCESSING OR USING THE SOFTWARE, YOU AND THE BUSINESS ENTITY OR THE ORGANIZATION YOU REPRESENT (“YOU” OR “YOUR”) INDICATE YOUR AGREEMENT TO BE BOUND BY THE TERMS OF USE.

2. Scope

The Terms of Use govern your use of the Software and all applications, content, software, online and services (collectively, “Content”) available via the Software, except to the extent such Content is the subject of a separate agreement.

Note that access to Dacima’s software products are governed solely by the contractual agreements under which they are licensed/subscribed with the customer that has contracted with Dacima. Your access will be granted by Dacima or and authorized user of the customer that has contacted with Dacima.

Dacima reserves the right to modify and update its security policies and procedures, privacy policy and Terms of Use as needs dictate and as legal requirements are updated. If and when a change is made to our security policy, privacy policy or Software Terms of Use, this page will be duly updated to reflect the change. Your continued use of the Software after any changes to these policies and Terms of Use will mean that you accept those changes.

3. For Free Trial Users

For users who have been granted access as a trial user under a Trial License Agreement signed between your company or organization and Dacima, you will be granted access for a trial period specified in the Trial License Agreement, beginning on the date of new account creation, to evaluate the software and utilize Dacima training resources at no extra cost. Dacima will create one or more trial or sandbox studies/projects on a sandbox database. This is a non-production database that is used for evaluation of the software only.

The Trial access is solely for evaluation purposes and it is not permitted to use the Software for a live/production study/project. For production or live studies/projects a subscription or license contract with Dacima will be required.

Training and support on is limited to 2 hours of initial training, and basic technical support.

4. Use of Cookies

We use cookies to identify the user’s session and for authentication purposes. You consent to our cookies and must insure that you have not blocked our cookies in order to use the Software.

5. Allow Popups

The Software requires that you allow popup for proper functioning of the software. For proper functioning of the Software you must insure that you have disabled popup blocking on your browser(s).

6. Encryption

The Software is designed as a secure EDC software application and database to ensure that access to any data stored in the database is protected from unauthorized access. The transfer of data from your browser to the server is encrypted using SSL/TLS encryption and the database is encrypted.

7. Your Account

The Software allows for the creation of multiple study or project databases by the company or organization that has contracted with Dacima for the user of the Software. Your account and access has been created and assigned by the administrator user(s) of the study/project at your company or organization, and the specific roles, permissions and rights to different features has been assigned based on the level of access you require. Depending on the roles assigned you may have access to one or more studies/projects. If you require access to specific modules, features or studies/projects you should contact the administrator to request a change to you access roles or permissions.

8. Your Responsibility

Access to the Software requires a unique username and password.

However, to prevent and minimize the risk of unauthorized access to the database you MUST take necessary precautions to prevent unauthorized access to your user account, including but not limited to:
i. Not sharing your username(s) and passwords.
ii. Not sending your permanent username or passwords via email.
iii. Not writing your usernames and password on documents (paper or electronic) and storing such documents so that they can be accessed by unauthorized users.
iv. Install antivirus and anti-spyware software on your computer(s).
v. Not assisting other individuals, companies or organization in gaining unauthorized access to the Software.

9. Two-Factor authentication

The software includes the option to configured a study/project for two-factor authentication. Whether this has been enabled for the study/project will depend on the design requirements and configuration of this study/project. If you require two-factor authentication at your company or institution you should contact the study/project administrator.

10. Dacima Respects Your Privacy

All Information Dacima collects about you and from you is stored and maintained on servers utilizing reasonable and appropriate data security safeguards. Dacima does not lend, lease, sell, or market information it obtains from its customers and users, who provide personally identifiable information.

Dacima may disclose or report Confidential Information in limited circumstances where it believes in good faith that disclosure is required under the law. For example, Dacima Clinical Suite may be required to disclose Confidential Information to cooperate with regulators or law enforcement authorities, to comply with a legal process such as a court order, subpoena, search warrant, or a law enforcement request. Additionally, if the ownership of all or substantially all of our business changes or we otherwise transfer assets relating to our business to a third party, such as by merger, acquisition, bankruptcy proceeding or otherwise, we may transfer your personal information to the new owner. In such a case, unless permitted otherwise by applicable law, your information would remain subject to the promises made in the applicable privacy policy unless you agree differently.

11. Medical Coding

Medical auto-coding is accomplished through the Dacima Clinical Suite Coding module. This can be licensed separately through the subscription agreement with the Customer along with an active study license/subscription that covers the study/project. Depending on the contract this can involve different coding dictionaries, such as MedDRA and WHODrug. Use of the coding module may require that you purchased a license for the company or organization that owns the intellectual property to the coding dictionaries. Dacima will only activate the coding module subject to confirmation that you company, organization, sponsor or institution that has contracted with Dacima is in possession of a valid license for the coding dictionary.

For more information, please contact Dacima.

12. The right to be forgotten

Under the General Data Protection Regulation (GDPR), an EU citizen has the right to demand an organisation erases their personal data if:

the data is no longer relevant to the reason it was collected;
if the person withdraws their consent for their data to be used (and if the organisation has no other legal basis for collecting it);
if the person objects to their data being collected for marketing purposes or where their rights override legitimate interests in collecting data (for instance, where that is sensitive data concerning a child);if the data was unlawfully processed;
if the data’s erasure is necessary to comply with a legal obligation;
if the data belongs to a child, and was exchanged for “information society services”.

There are some exceptions to the right to be forgotten. For example, GDPR does not supersede any legal requirement that an organization maintain certain data. This would include HIPAA health record requirements.
When you user account is created, in additional to your username, first and last name, the administrator may have also included contact information. This information is used solely for the purpose of identifying you as a user of the Software. If you would like any of your personal data removed you should contact the administrator at your company or organization to request removal of personal information.

13. Warranties

Dacima represents and warrants that (i) Dacima is the owner of the Software, has all title, rights and interests in and to the Software, and can grant the licenses and Subscription granted to Licensee hereunder, and can provide any data management services or other services provided for in connection with said Software; (ii) the Software will operate substantially in accordance with its Published Product Specifications, Software Documentation and intended use; and (iii) to the best knowledge of Dacima, the Software does not infringe on the intellectual property or proprietary rights of a third party.

Dacima further warrants that the Software will perform in accordance with its Published Product Specifications and Software Documentation and intended use, in effect at the Effective Date of this Contract between the customer and Dacima under which you as a user have been granted access. Dacima further warrants that the Dacima Published Product Specifications are accurate in all material respects.

Dacima further warrants that the Software, when used in accordance with its Published Product Specifications, shall in all material respects be properly operational and capable, provided that all other products (e.g. hardware, software, middleware, firmware, and any other systems) used in combination with the Software properly function with the Software.

14. Warranty Exclusions

DACIMA DOES NOT WARRANT THAT THE SOFTWARE IS ERROR OR BUG FREE, OR THAT USE OF DACIMA’S SOFTWARE OR DACIMA’S SERVICES WILL BE UNINTERRUPTED DURING THE ENTIRE TERM OF THE CONTRACT IN EFFECT BETWEEN THE CUSTOMER AND DACIMA.

THE CONTRACT UNDER WHICH YOU HAVE BEEN GRANTED ACCESS AS A USER PROVIDES FOR A SUBSCRIPTION, SERVICES, AND IF APPLICABLE SOFTWARE DEVELOPMENT AND CUSTOMIZATION, A LICENSE TO SOFTWARE COMPONENTS OR MODULES, AND IS NOT A SALE OF GOODS.

EXCEPT AS EXPRESSLY SET FORTH IN THE CONTRACT BETWEEN THE CUSTOMER AND DACIMA, DACIMA MAKES NO WARRANTY, EXPRESS OR IMPLIED, REGARDING ACCESSORY SOFTWARE OR ANY MODIFIED PORTIONS OF THE SOFTWARE NOT PROVIDED BY DACIMA.

DACIMA MAKES NO WARRANTY AS TO THE PERFORMANCE OF ANY HARDWARE OR THIRD PARTY SOFTWARE TO ATTAIN SOME OR ALL OF THE PERFORMANCE OBJECTIVES OF CUSTOMER OR ANY USERS ASSIGNED ACCESS TO THE SOFTWARE. MANY FACTORS, INCLUDING BUT NOT LIMITED TO THE TYPE OF NETWORK, THE AMOUNT OF THE TOTAL NETWORK TRAFFIC, AND THE TYPE AND PATTERN OF USAGE OF THE SOFTWARE OR OTHER SOFTWARE ON THE NETWORK WILL IMPACT THE PERFORMANCE OF THE SOFTWARE INSTALLED ON SUCH NETWORK.

DACIMA SHALL HAVE NO RESPONSIBILITY FOR PROBLEMS IN THE SOFTWARE WHICH ARE CAUSED BY ALTERATIONS OR MODIFICATIONS MADE BY CUSTOMER OR A THIRD PARTY NOT AUTHORIZED BY DACIMA, ARISING OUT OF THE MALFUNCTION OF CUSTOMER’S OR USER’S EQUIPMENT, OR CAUSED BY PROBLEMS IN OTHER SOFTWARE PRODUCTS OTHER THAN THE ONE(S) FOR WHICH THE SOFTWARE WAS CREATED OR NOT LICENSED BY DACIMA.

15. Limitation of Liability

THE PARTIES EXPRESSLY ACKNOWLEDGE AND AGREE THAT DACIMA AND ITS SUPPLIERS AND LICENSORS PROVIDE THE SOFTWARE “AS IS”, THAT IS AS DESCRIBED IN THE SOFTWARE DOCUMENTATION AND THE PUBLISHED PRODUCT SPECIFICATIONS.

TO THE EXTENT NOT PROHIBITED BY LAW, IN NO EVENT SHALL DACIMA BE LIABLE FOR ANY INCIDENTAL, SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER, INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS, BUSINESS INTERRUPTION, OR ANY OTHER COMMERCIAL DAMAGES OR LOSSES, ARISING OUT OF OR RELATED TO THE USE OR INABILITY TO USE THE SOFTWARE, HOWEVER CAUSED, OR THE EXERCISE OF THE RIGHTS GRANTED HEREUNDER REGARDLESS OF THE THEORY OF LIABILITY (CONTRACT, EXTRA-CONTRACTUAL OR CIVIL LIABILITY, TORT OR OTHERWISE) AND EVEN IF DACIMA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

16. Intellectual Property

Dacima retains all intellectual property right to the Software and any code that is developed or requested by the company, organization or user in fulfillment of software customization requests. The users granted access by the customer with whom Dacima has a contract shall comply with all applicable statutes of Canada relating to the identification of Licensed Patent(s) and the Trademark and packaging of the Software with patent pending indication, patent number(s), copyrights, trade-mark indication, or other intellectual property notices and legends required to maintain and protect the intellectual property rights licensed in this Contract.

Users shall NOT:
i. Reverse engineer any part of the Software or assist other parties in reverse engineering the Software;
ii. Provide access to the Software or share documentation about the Software with any competitors, companies, or organization without the expressed written permission from Dacima.
iii. Distribute, sell or otherwise transfer any part of the Software to a third party; and
iv. Remove the patent, copyright, trade secret, Trademark, or other proprietary protection legends or notices that appear on or in the Software.

17. Termination for Breach

Dacima, at its sole discretion, may terminate your access to the Software.