By using the Website You confirm that You accept these Terms and that You agree to comply with them. If You do not agree to these Terms, You must exit the Website immediately and refrain from using it. Other Applicable Terms These Terms refer to the following additional terms, which also apply to Your use of the Website:
- Our Privacy Statement, which sets out the terms by which any personal data collected from You or that You provide is processed. You must read Our privacy statement, which contains important information about the use of Your personal data, other information regarding Your privacy and Our security processes and policies. By using the Website You consent to such processing and You warrant that all such data provided by You is accurate.
- Our Cookie Statement, which sets out information about the cookies on the Website. Any use of the Website not expressly permitted by these Terms is a breach of these Terms and may also violate copyright, trademark and other laws. In the event that You breach these Terms, Your right to use the Website will terminate immediately and You must, at Our option, return or destroy any copies of the materials You have made or obtained from the Website.
Information About Us
The Website, its domain name and associated sub-domains are operated by Clinical Ink (“We” or “Us” or “Our”). We are registered in Winston-Salem, NC and have our offices at 525 Vine Street, Suite 130, Winston-Salem, NC 27101. If You have any questions, complaints or comments on the Website then You may write to us at the above address, use the “Contact Us” feature on the Website or use addresses at the end of these Terms.
Changes to These Terms
We may revise and update these Terms at any time by amending this page. All such changes take effect once they have been posted on the Website. Please check this page from time to time to take notice of any changes We have made, as they are binding on You. Your continued use of the Website following the posting of any revised Terms means that You accept and agree to the changes.
Changes to the Website
We are constantly looking for ways to improve the Website. Therefore, We may update and change the content of the Website at any time. However, please note that at any given time, some content on the Website may be out of date and, except as required by law, We are under no obligation to update it.
Reliance on Information
All content on the Website is provided on an ‘as is’ and ‘as available’ basis. We do not make any representation or make any promise (whether express or implied) in respect of the Website or its content, including, without limitation, its accuracy or completeness or any advice given and statements made on or via the Website or any forward-looking statements. Therefore, We disclaim, to the fullest extent permitted by law, any and all liability and responsibility arising from any reliance placed on such materials by You or any visitor to the Website, or by anyone who may be informed of any of its contents. Any decisions or actions taken by You on the basis of information provided on or via the Website are at Your sole discretion and risk and You should obtain professional or specialist advice where necessary. Nothing in this paragraph shall restrict Your statutory rights (including Your rights to receive a reasonable standard of service).
Accessing the Website
The Website is offered as a free service to You and Your access is permitted on a temporary basis. We reserve the right to suspend, withdraw, discontinue or amend all or any part the Website without notice to You. While We use all reasonable endeavors to correct any errors or omissions as soon as practicable once they have been brought to Our attention, We do not represent or guarantee that the Website, or any content on it, will always be available or be uninterrupted or free from errors or omissions.
We take reasonable precautions to prevent viruses and malicious code on the Website. However, You are responsible for configuring Your information technology, computer programs and platform in order to access the Website. You should use Your own virus protection software and You are responsible for ensuring that anything downloaded from the Website is suitable for use on Your computer and is free from viruses and malicious code. Accordingly, We exclude, to the fullest extent permitted by law any, and all liability that may arise in connection with or as a result of any failure to do so.
Access to the Website may be suspended temporarily and without notice in the case of system failure, maintenance or repair or for reasons reasonably beyond Our control. We will not be liable if for any reason the Website is unavailable at any time or for any period. You are responsible for making all arrangements necessary for You to have access to the Website. You are also fully responsible for ensuring that any person who has access to the Website through Your internet connection is aware of these Terms and that they comply with them.
You may access most areas of the Website without registration. However, We may. at Our sole discretion. restrict access to all or some parts of the Website to limited groups of users such as users who have registered with Us.
Registration & Account Security
To access any restricted areas of the Website, You may be asked to provide certain registration details or other information. If You choose, or You are provided with, a user identification code, password or any other piece of information as part of Our security procedures, You must treat such information as confidential. You must not disclose it to any third party. It is a condition of your use of the Website that all the information you provide on the Website is correct, current and complete.
If You know or suspect that anyone other than You knows Your user identification code or password, or if You become aware of any unauthorized use of Your user name or password or any other breach of security, You must promptly notify Us in writing to Website Security, 525 Vine Street, Suite 130. You should ensure that You exit from Your account at the end of each session and You should use particular caution when accessing Your account from a public or shared computer so that others are not able to view or record Your password or other personal information.
We have the right to disable any user identification code or password, whether chosen by You or allocated by Us, at any time if, in Our reasonable opinion, You have failed to comply with any of the provisions of these Terms.
Intellectual Property Rights
We are the owner or the licensee of all intellectual property rights in the entire Website (including, without limitation, copyright and database rights (including software) and any logos or trademarks (whether registered or unregistered)) and in the material published on it, including, without limitation, logos, graphics, photographs, animations, signage, livery, get-up, videos, audio, stationery, publications, reports and text). Those works are protected by United States and international laws regarding copyright, trademark, trade secrets and other intellectual property or proprietary rights around the World.
Your use of the Website and its contents does not grant You any rights to Our intellectual property or the intellectual property of third parties in the Website and its contents. Unless otherwise stated, third parties (e.g. business partners, customers and associates) who publish their content on the Website retain full copyright ownership of their material. Other than as expressly permitted in these Terms, You may not copy, reproduce, republish, download, post, broadcast, record, transmit, commercially exploit, edit, communicate to the public or distribute in any way the services, web pages or materials on the Website or the computer codes of elements comprising the Website.
You may download or print insubstantial extracts of the content of the Website to Your hard disk for the sole purpose of viewing it. In downloading or printing any content from the Website, You must not remove or amend any trademark, copyright notice or other proprietary notice, legend or restriction including product identification details from any of the material or information contained on pages of the Website. In addition, You are not allowed to modify, in any way, the paper or digital copies of any materials You have printed or downloaded.
You must not use any part of the materials on the Website for commercial purposes without obtaining a license to do so from Us or Our licensors. You may not copy or republish any such information in any other manner without Our prior written consent. Any use other than that permitted under this section may only be undertaken with Our prior express authorization.
Clinical Ink is a registered trademark of Clinical Ink LLC. In addition, certain words, phrases, logos, icons, graphics or designs used on the pages of the Website may constitute trade names or registered or unregistered trademarks of Ours or our affiliated companies. The display of any trade names or trademarks on the Website does not imply that any license has been granted to You.
All third party product or company names, devices, logos, icons, graphics or designs referred to on the Website are or may be trademarks of their respective owners and are exhibited in good faith and in such a manner as intended to be for the benefit of such trademark owners. We do not give permission for their use by any person other with the consent of their owners. Any such use without consent may constitute an infringement of the owner’s rights. The appearance or absence of any third party products, services, companies, organizations, homepages or other websites on the Website does not imply any endorsement or non-endorsement by Us.
Your Conduct & Use of the Website
You may use the Website only for lawful purposes and in accordance with these Terms. You agree to use the Website (or any part of it) in accordance with all applicable laws relevant to the jurisdiction from which You access the Website.
You agree that in using the Website (or any part thereof) You will not:
- Use the Website in any way that may lead to the encouragement, procurement or carrying out of any criminal or other activity that violates any applicable federal, state, local and international law or regulation;
- Use the Website in a manner that infringes the rights of another person, firm or company (including, without limitation, the intellectual property rights, confidentiality rights or rights of privacy);
- Introduce or transfer through the Website material that is defamatory, libelous, obscene, offensive, threatening, menacing or blasphemous, or material that may cause annoyance inconvenience or needless anxiety;
- Use the Website to impersonate or attempt to impersonate Us or one of Our employees, another user or person or entity (this includes, without limitation, the use of email-addresses associated with any of the foregoing);
- Engage in conduct that restricts or inhibits anyone’s use or enjoyment of the Website, or which, as determined by Us, may harm Us or users of the Website or expose them to liability;
- Transfer files to or through the Website that contain viruses, Trojans, worms or anything else that is malicious or technologically harmful or that may interfere with, interrupt or disrupt the normal operation of the Website;
- Use the Website in a way to cause it to be interrupted, overburdened, damaged, rendered less efficient or in a way so that the effectiveness or functionality of the Website is impaired;
- Use the Website to send any unsolicited advertising or other promotional material or any form of solicitation by email or by any other means;
- Do anything that would seek to bypass or interfere with any security features of the Website, or interfere with any of Our (or Our affiliated companies) websites, servers, or network;
- Use any robot, spider or other automatic device, process or means to access the Website;
- Use any manual process to monitor or copy any of the material on the Website, or for any unauthorized purpose without Our express prior written consent;
- Attempt to gain unauthorized access to any part or component of the Website, the server on which the Website is stored or any server, computer or database connected to the Website;
- Attack the Website via a denial-of-service attack or a distributed denial-of-service attack;
- Upload files which contain an active hypertext link to another website; and
- Permit or procure any third party to do any of the above. In the event that You have a claim against another user of the Website arising out of that user’s use of the Website, You agree to pursue such right, claim or action independently of and without recourse to Us.
Your Legal Obligations/Your Promises to Us
You confirm that:
- All information and details provided by You to Us (including on registration, if applicable) are true, accurate and up-to-date in all respects and at all times;
- You will comply with the restrictions on Your use of the Website as set out in the “Conduct and Use of the Website” section above and as set out elsewhere in these Terms; and
- In relation to any material submitted to the Website, You have the right to do so and have obtained all necessary licenses and or approvals.
You agree to compensate Us in full from any claim or damages (including any legal fees in relation to such claim or damages) made by a third party in respect of any matter in relation to or arising from Your use of the Website including any breach or suspected breach of these Terms or Your violation of any law or the rights of a third party.
You agree to defend, indemnify and hold harmless Us, Our affiliated companies and licensors and their respective officers, directors, employees, contractors, agents, licensors and suppliers from and against all claims, liability, damages, losses, costs and expenses, (including legal fees) arising out of any breach of the Terms by You (including in relation to any Materials submitted by You) or any other liabilities arising out of Your use of the Website other than as expressly authorized in these Terms or your use of any information obtained from the Website or the use by any other person who accesses the Website using Your internet account.
Our Legal Obligations & Limits on Liability
Nothing in these Terms shall exclude or limit Our liability for fraudulent misrepresentation or for death or personal injury resulting from Our negligence or negligence by Our employees or agents nor for any other liability which cannot be excluded or limited under applicable law. We do not accept any liability for:
- Damage to Your computer system or loss of data or other proprietary material that results from Your use of the Website or in connection with Your downloading of any material posted on it, or on any website linked to it, unless such damage results from Our negligence; and
- Any loss, damage, expense, costs, delay or other liability whatsoever (including without limitation any financial losses such as loss of profit) which You may incur as a result of any event beyond Our reasonable control (including without limitation any failure of transmission, communication, computer or other facilities or Your inability to access the Website for any reason or any failure, error or delay in the sending or receiving of any notice or communication or instruction through the post or any electronic medium).
To the extent permitted by law, We and Our affiliated companies hereby expressly exclude:
- All conditions, warranties and other terms which might otherwise be implied by statute, common law or the law of equity; including without limitation any warranties of merchantability, non-infringement and fitness for a particular purpose;
- Any liability for any direct, indirect or consequential loss or damage incurred by You in connection with the Website or in connection with the use, inability to use, or results of the use of the Website, any websites linked to it and any materials posted on it, including, without limitation any liability for (i) loss of income or revenue; (ii) loss of business; (iii) loss of profits or contracts; (iv) loss of anticipated savings; (v) loss of data; (vi) loss of goodwill; (vii) wasted management or office time; (viii) computer failure; and (ix) for any other loss or damage of any kind, howsoever arising and whether caused by tort (including negligence), breach of contract or otherwise, even if foreseeable.
We will not be liable for any loss or damage caused by a virus, distributed denial-of-service attack, or other technologically harmful material that may infect Your computer equipment, computer programs, data or other proprietary material due to Your use of the Website or to Your downloading of any content on it, or on any website linked to it.
Linking to the Website
You may establish a link to the Website provided that:
- You link only to the home page of the Website;
- the link is to a website owned by You;
- the link is fair and legal and does not damage Our reputation or take advantage of it;
- the link does not suggest any form of association, approval or endorsement on Our part where none exists;
- You do not remove or obscure advertisements, copyright notices or any other proprietary, legal or trademark notices on the Website; and
- the Website is not be framed on any other site.
We reserve the right to withdraw Your linking permission without notice and You must immediately stop providing links to the Website if notified by Us.
Links to Third Party Websites
We may provide links to other websites from time to time (via advertising or otherwise). We do not supply reciprocal links to third party websites solely because they have linked to Us. These links are provided for Your ease of reference and information only. We do not control such third party websites and are not responsible for their contents. Our inclusion of links does not imply any endorsement of the material contained in such websites nor any association with their operators.
If You decide to access any of the third party websites linked to this Website, You do so entirely at Your own risk and subject to the terms and conditions of use for such websites You acknowledge that We will not be party to any transaction or contract with a third party that You may enter into and We shall not, to the fullest extent permitted by law, be liable to You in respect of any loss or damage which You may suffer by using those websites. You agree that You will not involve Us in any dispute between You and the third party.
We reserve the right to take appropriate legal action, including without limitation, referral to law enforcement, for any illegal or unauthorized use of the Website. We also reserve to right take any action to prevent the unauthorized use of Our intellectual property rights.
We may co-operate with any law enforcement authorities or court order requesting or directing Us to disclose the identity of or locate anyone breaching or in breach of the Conduct and Use of the Website Section above or otherwise for the prevention or detection of crime or the apprehension or prosecution of offenders. There may be other circumstances in which We may be required by law to disclose information about You or Your use of the Website. You waive and hold Us harmless from any claims resulting from any action taken by Us during or as a result of its investigations and from any actions taken as a consequence of investigations by either Us or law enforcement authorities.
We may investigate any reported breach of these Terms or complaints and take any action that We deem appropriate (which may include, without limitation, removing any of Your information, issuing warnings, suspending, restricting or terminating Your access to and/or removing any Materials from the Website. We also reserve the right at Our discretion to suspend, restrict or terminate Your access to this Website at any time without notice if We have reasonable grounds to believe that You have breached any of the restrictions in the Conduct and Use of the Website section above.
Severance & Waiver
If any provision of these Terms is found by a court or a regulator to be invalid or unenforceable for any reason, such provision shall be eliminated or limited to the minimum extent such that the remaining provisions shall continue to apply.
No waiver of these Terms by Us shall be deemed a further or continuing waiver of such term or condition or any other term or condition, and any failure by Us to assert a right or provision under these Terms shall not constitute a waiver of such right or provision.
Governing Law & Jurisdiction
In the event of any dispute between You and Us concerning these Terms or any claim arising from, or related to, a visit to the Website, the laws of the State of New Jersey will apply without giving effect to any choice or conflict of law provision or rule. If You wish to take court proceedings against Us You must do so exclusively in the federal courts of the United States or the courts of the State of North Carolina. However, We retain the right to bring proceedings against You for breach of these Terms in Your country of residence or any other relevant country. You agree to waive any and all objections to the exercise of jurisdiction over You by such courts and to venue in such courts.
The Website is controlled and operated by Clinical Ink, Inc. from the United States. We make no representations that materials in the Website are appropriate or available for use in other locations. Those who choose to access the Website from other locations do so at their own risk and are responsible for compliance with any and all local laws, if and to the extent local laws are applicable.
If You have any concerns about material which appears on the Website, or if You wish to report any inaccuracies or faults on the Website, or if You have any other suggestions about how the content can be improved, please contact Us at the address below. If You wish to make any use of material on the Website other than that set out above, please contact Us at the address below.
If You have any questions concerning these Terms please write to Clinical Ink: Website Inquiries c/o Clinical Ink; 525 Vine Street, Suite 130, Winston-Salem, NC 27101.
Clinical Ink is strongly committed to protecting the privacy of your personal information. This privacy statement explains Clinical Ink’s information collection and use practices with respect to its website (the “Site”). By using the pages in this site, you agree to the information collection and use practices described in this privacy statement.
Clinical Ink is a provider of software and services to life sciences companies for use in the conduct of clinical trials throughout the world. Acting as a third-party agent for our clients, for each clinical project Clinical Ink receives Personal Data (name, email, phone number) from study sponsors, research site staff, study participants, various consultants/subcontractors, and employees. Additionally, as specifically authorized by our customers, Clinical Ink may also collect and store Clinical Study Data, which is collected pursuant to a project-specific informed consent with clinical research subjects, and may include detailed information regarding health status, medical assessments, test results and other data required for a particular study. Detailed contractual arrangements, SOPs and business policies govern all our work with customer data. Clinical Ink’s internal policies are available for audit/review by our clients.
Clinical Ink institutes precautions to protect against reasonably foreseeable internal and external risks to the security, confidentiality and integrity of Personal Data and Clinical Study Data.
EU-US Privacy Shield and US-Swiss Safe Harbor Certification Statement
Clinical Ink is a provider of software and services to life sciences companies for use in the conduct of clinical trials throughout the world. Acting as a third-party agent for our clients, for each clinical project Clinical Ink receives Personal Data (name, email, phone number) from study sponsors, research site staff, study participants, various consultants/subcontractors, and employees. Additionally, as specifically authorized by our customers, Clinical Ink may also collect and store Clinical Study Data, which is collected pursuant to a project-specific informed consent with clinical research subjects, and may include detailed information regarding health status, medical assessments, test results, and other data required for a particular study. Detailed contractual arrangements, SOPs and business policies govern all our work with customer data. Clinical Ink’s internal policies are available for audit/review by our clients; provided that Clinical Ink remains responsible for the adequacy of our business practices and technical infrastructure.
Consistent with principles outlined in both the EU-US Privacy Shield Framework and US-Swiss Safe Harbor Framework; Clinical Ink complies with and institutes precautions to protect against reasonably foreseeable internal and external risks to the security, confidentiality, and integrity of the Personal Data and Clinical Study Data. Clinical Ink has certified that it adheres to the EU-US Privacy Shield Principles of Notice, Choice, Accountability for Onward Transfer, Security, Data Integrity and Purpose Limitation, Access, and Recourse, Enforcement and Liability. Additionally, Clinical Ink has certified that it adheres to the US-Swiss Safe Harbor principles of Notice, Choice, Onward Transfer, Access, Security, Data Integrity and Enforcement. To learn more about the EU-US Privacy Shield and to view Clinical Ink’s certification, please visit the EU-US Privacy Shield website (https://www.privacyshield.gov). To learn more about the US-Swiss Safe Harbor framework and to view Clinical Ink’s certification, please visit the US-Swiss Safe Harbor website (https://build.export.gov/main/safeharbor/swiss/index.asp).
Definition of Terms
“Personal Data” means any data or combination of data that could potentially identify a specific individual and includes information such as Name, Email, Address, or any other data that could be linked to a particular person. Personal Data does not include information that is stored in an anonymized format or is otherwise publicly available.
“Sensitive Data” pertains to data that reflects racial or ethnic origins, health, or sexual orientation and activities. Clinical research studies often collect data categorized as “sensitive”, however, a requirement of clinical research (Good Clinical Practices, GCP) requires that enrolled subjects have completed and signed an Informed Consent (IC) that notifies them of the requirements of the study, including the data (personal and sensitive) that will be collected and processed as a part of the study conduct.
“Clinical Study Data” means the specific details of an identifiable individual with respect to medical history, prescription drug use, clinical observations or test results, and other medical records. Personal Data may also be considered Clinical Study Data if collected for the purpose of conducting a clinical trial.
The term “Data Subject” means an individual who is the subject of personal data. In other words, the data subject is the individual whom particular personal data is about.
A data subject is not an individual who has died or who cannot be identified or distinguished from others.
Clinical Ink intends that its corporate privacy policies, internal SOPs and work practices are adequate to ensure compliance with applicable international laws and regulations including the US Health Insurance Portability and Accountability Act (HIPAA), the European Union’s Data Protection Directive (EUDP), and other similar guidelines. Clinical Ink is a self-certifying participant in the EU-US Privacy Shield Framework and the US-Swiss Safe Harbor Framework. Clinical Ink has developed policies related to data collection, security, and privacy in a manner consistent with the requirements of the EU-US Privacy Shield certification process.
In all cases where Clinical Ink is acting on our own behalf, such as with employee or customer Personal Data, the collection vehicle will specifically provide notice stating the purpose for which the information is being collected and how that information will be stored. As a Software-as-a-Service (SaaS) provider of clinical trial software and services, Clinical Ink acts as an agent on behalf of clients to collect Clinical Study Data.
With respect to all Clinical Study Data, Clinical Ink shall act in a manner governed by the contractual relationship with each customer consistent with the notice provisions specified by the customer in their relationship with the individuals participating in the clinical study. Clinical Ink will disclose all information regarding how Clinical Study Data is secured in order to facilitate customer’s Notice responsibilities.
Data Subjects may initiate a request relating to their data, and, under certain circumstances, may invoke binding arbitration. Clinical Ink will use commercially reasonable efforts to respond to individual requests within forty-five (45) days of receipt of such request and proper identity verification. All requests in this regard should be submitted via email to firstname.lastname@example.org.
Clinical Ink may share Clinical Study Data with agents, third-parties, or partners approved by our customers and as required by contract. Therefore, Clinical Ink is liable for the onward transfers to these approved agents, third-parties, or partners.
Additionally, it is important to note that Clinical Ink may be required to disclose the personal information of individuals, including certain personally identifiable information, in response to a lawful request by public authorities or under any applicable law, including to meet national security or law enforcement requirements.
By self-certifying with the Privacy Shield, Clinical Ink is subject to the investigatory and enforcement powers of the Federal Trade Commission (FTC).
Clinical Ink will not share Personal Data with third parties except in cases where the third party is acting on behalf of Clinical Ink consistent with the purposes for which such Personal Data was originally obtained. All Clinical Study Data is owned by our customer who retains the responsibility to permit individuals to withdraw consent to have their personal Clinical Study Data used for purposes other than for the originally intended purpose.
ACCOUNTABILITY FOR ONWARD TRANSFER:
Clinical Ink may share Clinical Study Data with agents, third-parties, or partners approved by our customers and as required by contract. Clinical Ink will not disclose any Clinical Study Data to third-parties without explicit approval from our Customer. In cases where Clinical Ink contracts with a third-party, then Clinical Ink will obtain assurances that they will safeguard Personal Data and Clinical Study Data in a manner consistent with this Policy.
Furthermore, when transferring personal information to a third party acting as an agent, Clinical Ink will:
- transfer such data only for limited and specified purposes;
- ascertain that the agent is obligated to provide at least the same level of privacy protection as is required by the Privacy Shield Principles;
- take reasonable and appropriate steps to ensure that the agent effectively processes the personal information transferred in a manner consistent with the organization’s obligations under the Principles;
- require the agent to notify the organization if it makes a determination that it can no longer meet its obligation to provide the same level of protection as is required by the Principles;
- upon notice, including under (iv), take reasonable and appropriate steps to stop and remediate unauthorized processing; and
- provide a summary or a representative copy of the relevant privacy provisions of our contract with that agent to the Department of Commerce or Federal Trade Commission upon verified request.
Clinical Ink will employ reasonable safeguards to protect Personal Data from loss, misuse, unauthorized access, disclosure, alteration and destruction. Clinical Ink strictly controls access to Clinical Study Data through multiple security mechanisms and adheres to a Defense-In-Depth approach with regard to data security which includes the following:
- multiple physical data center security controls,
- physical server rack controls,
- environmental monitoring,
- anti-virus software,
- permit-only firewalls,
- database logging and auditing,
- multi-factor authenticated VPN,
- encrypted communications,
- anonymization of certain data elements.
DATA INTEGRITY AND PURPOSE LIMITATION:
Clinical Ink facilitates the collection of Personal Data and Clinical Study Data as specified by our customer. Customers must also receive the appropriate regulatory and oversight approvals (e.g. FDA, EMA, Institutional Review Boards, etc.) necessary to conduct the clinical trial. Clinical Ink does not own or have any rights to any Clinical Study Data and makes no decisions based on such data.
Additionally, Clinical Ink takes reasonable steps to ensure that personal data is reliable for its intended use, accurate, complete and current. Clinical Ink adheres to these principles as long as such information is retained.
Upon request, Clinical Ink will facilitate reasonable access to personal information, made by a clinical research participant, received by customers, in the course of fulfilling contractual obligations to collect and store Clinical Study Data. Clinical Ink does not work directly with clinical trial subjects or investigative sites to correct/modify Clinical Study Data. With respect to Personal Data maintained solely on behalf of Clinical Ink, upon request, will provide reasonable means to ensure such data is accurate. In particular, Clinical Ink employees have a responsibility to ensure that all Personal Data is updated regularly as changes occur.
It must be noted that Clinical Ink may deny an access request where the burden or expense of providing access would be disproportionate to the risks to the individual’s privacy in the case in question, or where the rights of persons other than the individual would be violated. Such decisions would be documented in writing and retained for future access.
RECOURSE, ENFORCEMENT AND LIABILITY:
Clinical Ink will fully cooperate with all customer requests to investigate potential violations related to Clinical Study Data. Individuals, including employees, who feel that Clinical Ink has violated this Policy in any way, may contact the head of Quality & Compliance directly to initiate a formal inquiry. Employees found willfully disregarding this Policy shall be terminated.
Attn: Chief Privacy Officer
525 Vine Street, Suite 130
Winston-Salem, NC 27101
Clinical Ink is committed to refer unresolved privacy complaints under the EU-US Privacy Shield Principles to a non-profit alternative dispute resolution provider located in the United States, the International Centre for Dispute Resolution, A Division of the American Arbitration Association (ICDR/AAA). If you do not receive timely acknowledgment of a complaint, or if Clinical Ink does not satisfactorily address such complaint, please visit www.adr.org for more information or to file a complaint. You can also visit the U.S. Department of Commerce’s Privacy Shield website at https://www.privacyshield.gov/ to learn more information on the Privacy Shield Framework.
Disputes involving the handling of employee Personal Data shall be handled through an internal review process according to the severity of the complaint.
By self-certifying with the Privacy Shield, Clinical Ink commits to cooperate in investigations by EU Data Protection Authorities as well as comply with the advice of competent EU authorities in such cases.
Reservation of Rights
Clinical Ink reserves the right to share Personal Data as required by law in order to respond to duly authorized information requests of government authorities. For such requests involving Clinical Study Data, Clinical Ink shall provide notice to affected customers, but shall not necessarily seek permission, prior to disclosing any data to regulatory agencies.