“Affiliate” refers to a person or entity who is not a part of a COG Member Institution but who is nevertheless eligible to receive COG Data or other information based on such person or entity’s affiliation or employment relationship with a COG Member Institution (for example, study personnel in the clinic or laboratory of a COG Confidential Information recipient who work on COG Studies). An individual associated with an Affiliate may be named as an Authorized User.
“Authorized User Pledge” refers to the Authorized User Pledge for Website and Database Access by COG Member Institutions and Affiliates executed and acknowledged each time an Authorized User gains access to the COG Website.
“COG Confidentiality Agreement” refers to the agreement that COG Confidential Information Recipients of COG Confidential Information must execute.
“COG Confidential Information” includes “COG Data,” “COG Study,” “Industry Sponsor Study Drug, Data, Information and/or Materials,” “Industry Clinical Trials,” and all information, data, and materials, in any format, electronic, print, etc., unpublished or published, written or oral, including: ideas, designs, products, know-how, concepts, protocols, reports, statistical information (including statistical algorithms, designs or analyses), computer programs, prototypes, business plans, processes, drawings, specifications, compositions of matter, product applications, information and computer programming algorithms, procedures and processes, methods of use, operations, trade secrets, intellectual property, records, physical samples or specimens, and other physical materials:
(1) Disclosed to a COG Confidential Information Recipient by COG or any subdivision thereof, including, without limitation, the COG Chair, Co-Chair, the Executive Committee or any COG Disease Committee or other Committee, or the Public Health Institute (and/or the employees and agents of each thereof); or
(2) Generated or relating to a COG Study (defined below).
“COG Data” means all data and materials, including, without limitation, “Industry Sponsor Study Drug, Data, Information and/or Materials,” “Industry Clinical Trials” or any other data generated from analysis of materials (e.g., biological specimens or samples) based on research subjects who are entered onto a COG Study or study of related consortia housed with COG or which utilize the resources of COG including consortia such as the Pediatric Early Phase Clinical Trials Network (PEP-CTN), and others as may be added at a later time which are stated within COG communications, policy statements, and other documents issued by COG (and/or the Public Health Institute on behalf of COG), and excluding the comparable data and materials of other, unrelated programs and projects of the Public Health Institute. Such COG Data may be maintained in the Research Database.
“COG Study” refers to any study or research project, including any amendment to such study or project, or any proposed study or research project that is in the planning phase, conducted or to be conducted by COG including, without limitation, any conducted by or through the COG Network Group Operations Center and Network Statistics and Data Management Center and directed by the COG Group Chair’s Office, in collaboration with the COG Member Institutions and individual members (and related study personnel at each COG Member Institution) in conformance with COG policies and procedures as set forth in operational policies and procedures available on the COG Website, and includes any study utilizing a protocol that has been reviewed and approved by the appropriate scientific bodies. This includes, for example, the Pediatric Early Phase Clinical Trials Network (PEP-CTN) studies, studies led by other NCI Clinical Trial Networks that are open to COG, studies sponsored by COG pharmaceutical partners and others as may be added at a later time which are stated within COG communications, policy statements, and other documents issued by COG (and/or the Public Health Institute on behalf of COG). The foregoing Network Group Operations Center, Network Statistics and Data Management Center, and COG Group Chair’s Office receive funding and/or support in terms of staffing, facilities, or other resources from the Public Health Institute, which is the grantee organization for COG and acts as COG’s legal and fiscal agent.
“COG Website” refers to the collective body of all materials, features and functionality made available on the COG website, including without limitation COG Confidential Information or other access permitted under the Confidentiality Agreement.
“Industry Sponsor Study Drug, Data, Information and/or Materials” refers to any study drug (a drug, biologic, medical device, or agent), data, materials (reagents, biological specimens, etc.) or information associated with study drug supplied by and proprietary to an Industry Sponsor provided during an Industry Clinical Trial.
“Industry Clinical Trial” refers to any project, clinical trial, or research involving a relationship with industry, in particular, those involving novel, experimental or governmentally regulated products, uses or therapies regardless of whether the study is conducted group-wide by COG, by a specific consortium housed within or affiliated with COG (e.g., Phase 1, PBMTC) where COG resources (which could include facilities, staff, resources and support of the Public Health Institute), procedures and processes for study conduct are utilized, primarily or partially, and regardless of funding source.
“Industry Sponsor” refers to a private company or entity that participates, sponsors, and/or provides data, materials, or other information during the course of an Industry Clinical Trial or, as applicable, the authorized employee, agent or representative thereof. An Industry Sponsor may be a “Collaborator” as that term is used in the NCI-Cooperative Group-Industry Relationship Guidelines, http://ctep.cancer.gov/industryCollaborations2/guidelines.htm.
“Public Health Institute” refers to the Public Health Institute, a nonprofit public benefit corporation operated for charitable and scientific purposes, and COG’s legal and fiscal agent.
“Research Database” refers to the body of research, including COG Confidential Information, that serves as a resource made available to COG Confidential Information Recipients via the COG Website or through other means.
The COG Website is offered and available to Authorized Users who satisfy eligibility criteria of COG. For the purpose of performing work in furtherance of COG research, Authorized User status is available to an employee, volunteer, contractor or staff member of a COG Member Institution (participating institution), an NCI Clinical Trials Network Group, or an Affiliate thereof. By using the COG Website, an Authorized User represents and warrants satisfaction of eligibility requirements. If an individual does not meet all of these requirements, or if satisfaction of the requirements has lapsed in any way, the individual may not access or use the COG Website.
Accessing the COG Website and Account Security
COG reserves the right to withdraw or amend the COG Website, and any service or material provided on the COG Website, in COG’s sole discretion without notice. COG will not be liable if for any reason all or any part of the COG Website is unavailable at any time or for any period. From time to time, COG may restrict access to some parts of the COG Website, or the entire site, to users, including Authorized Users.
Authorized Users are responsible for making all arrangements necessary for responsible, safe and secure access to the COG Website.
To access the COG Website or some of the resources and functionality it offers, Authorized Users are asked to agree to an Authorized User Pledge acknowledged each time an Authorized User gains access to the COG Website. It is a condition of use of the COG Website that all the information provided on the COG Website is, to the best of the knowledge of the contributing Authorized User, correct, current, and complete. The Authorized User agrees that all information provided in regard to eligibility and satisfaction of criteria for access and use of the COG Website is accurate and complete. The Authorized User consents to abide by COG privacy policies and compliance considerations, specifically regarding use of information contained in or made available via the COG Website.
To that end, Authorized Users provided with a user name, password, or any other piece of information as part of COG security procedures must treat such information as confidential, and must not disclose this information to any other person or entity. Authorized Users also acknowledge that an account is personal and agree not to provide any other person with access to the COG Website or portions of it using a user name, password, or other security information.
Authorized Users agree to notify COG immediately of any unauthorized access, or suspected unauthorized access, to or use of the Authorized User’s user name or password or any other breach of security. Authorized Users further agree to make an exit from the account at the end of each session of use, and to use particular caution when accessing an account from a public or shared computer so that others are not able to view or record login, password, or other personal information.
Each Authorized User agrees not to disclose COG Data or other data accessible through the COG Website to any person or entity at any time without the prior written consent of COG authorized representatives. For COG Data provided by an Industry Sponsor of a COG Study, if not set forth in a COG protocol or other COG study document, Member Institution and/or Affiliate agrees to follow the direction of the COG Group Chair’s Office, or the COG Group Operations Center, or applicable divisions of the Public Health Institute that may support such divisions, with respect to use, disposal or return of COG Data.
Intellectual Property Rights
The COG Website and its entire contents, features, and functionality (including but not limited to all information, software, text, displays, images, video, and audio, and the design, selection, and arrangement thereof) are owned by COG, its licensors, or other providers of such material and are protected by United States and international copyright, trademark, patent, trade secret, and other intellectual property or proprietary rights laws.
· The computer of an Authorized User may be used temporarily to store copies of such materials in RAM incidental to accessing and viewing those materials.
· An Authorized User may store files that are automatically cached by a Web browser for display enhancement purposes.
· An Authorized user may print or download copies of a reasonable number of pages from the COG Website for individual research use and not for further reproduction, publication, or distribution, subject to applicable end user license agreements. Provided, however, that the Authorized User assumes responsibility for the protection and security of downloaded materials, including secure and confidential disposition, such as cross-cut shredding, of any downloaded materials into printed paper format, and adequate computer security measures not only for disposition but also preventive protection and security in the event of a computer breach.
An Authorized User must not:
· Modify copies of any materials from this site.
· Use any illustrations, photographs, video or audio sequences, or any graphics separately from the accompanying text.
· Delete or alter any copyright, trademark, or other proprietary rights notices from copies of materials from this site.
• Authorized User will not compile, distribute or sell any analyses to third parties utilizing any COG Data, including de-identified data, received from, or created or received on behalf of, COG without express written permission from COG except as set forth in a fully executed separate research agreement(s) between COG and the Member Institution.
• Member Institution agrees to execute any consents or other instruments that will permit the Public Health Institute to enforce the above obligations on behalf of COG, as its legal and fiscal agent, should such written documentation or consent become reasonably necessary to legally effectuate the obligations contained herein.
• Member Institution, Affiliates and Authorized Users shall agree to and comply with all instructions to destroy or return (at the sole discretion of COG, or the Public Health Institute acting as COG’s legal and fiscal agent) all copies of downloaded COG Data.
· In any way that violates any applicable federal, state, local, or international law or regulation (including, without limitation, any laws regarding the export of data or software to and from the US or other countries).
· For the purpose of exploiting, harming, or attempting to exploit or harm minors in any way by exposing them to inappropriate content, asking for personally identifiable information, or otherwise.
· To transmit, or procure the sending of, any advertising or promotional material including any “junk mail,” “chain letter,” “spam,” or any other similar solicitation.
· To impersonate or attempt to impersonate COG (and/or the Public Health Institute), an employee, another user, or any other person or entity (including, without limitation, by using email addresses associated with any of the foregoing).
· To engage in any other conduct that restricts or inhibits another Authorized User’s access to and use of the COG Website, or which, as determined by COG, may harm COG, the Public Health Institute, Authorized Users of the COG Website, or other persons.
Additionally, an Authorized User agrees not to:
· Use the COG Website in any manner that could disable, overburden, damage, or impair the site or interfere with any other party’s use of the COG Website, including their ability to engage in real time activities through the COG Website.
· Use any robot, spider, or other automatic device, process, or means to access the COG Website for any purpose, including monitoring or copying any of the material on the COG Website.
· Use any device, software, or routine that interferes with the proper working of the COG Website.
· Introduce any viruses, Trojan horses, worms, logic bombs, or other material that is malicious or technologically harmful.
· Attempt to gain unauthorized access to, interfere with, damage, or disrupt any parts of the COG Website, the server on which the COG Website is stored, or any server, computer, or database connected to the COG Website.
· Attack the COG Website via a denial-of-service attack or a distributed denial-of-service attack.
· Otherwise attempt to interfere with the proper working of the COG Website.
By posting on the COG Website, an Authorized User grants COG and its affiliates and service providers, and each of their respective licensees, successors, and assigns, as necessary and appropriate to the performance of a COG Study, the right to use, reproduce, modify, perform, display, distribute, and otherwise disclose to third parties any such material.
Authorized Users understand and acknowledge that they, not COG, are responsible for any Contributions of Authorized Userss, and that Authorized Users have full responsibility for the individual Contributions of Authorized Users, including its legality, reliability, accuracy, and appropriateness.
COG is not responsible or liable to any third party for the content or accuracy of any Contributions of Authorized Users posted by the Authorized User or any other user of the COG Website.
Monitoring and Enforcement; Termination
COG reserves the right to:
· Remove or refuse to post any contribution from an Authorized User for any or no reason in its sole discretion.
· Disclose the identity or other information about an Authorized User to any third party who claims that material posted by the Authorized User violates the rights of the third party, including their intellectual property rights or their right to privacy.
· Take appropriate legal action, including, without limitation, referral to law enforcement, for any illegal or unauthorized use of the COG Website.
Without limiting the foregoing, COG has and retains the right to cooperate fully with any law enforcement authorities or court order requesting or directing disclosure of the identity or other information of anyone posting any materials on or through the COG Website. AUTHORIZED USER WAIVES AND HOLDS HARMLESS COG, THE PUBLIC HEALTH INSTITUTE, AND THEIR AFFILIATES, LICENSEES, AND SERVICE PROVIDERS FROM ANY CLAIMS RESULTING FROM ANY ACTION TAKEN BY COG DURING, OR TAKEN AS A CONSEQUENCE OF, INVESTIGATIONS BY EITHER COG OR LAW ENFORCEMENT AUTHORITIES.
However, COG cannot practicably review all material before it is posted on the COG Website, and cannot ensure prompt removal of objectionable material after it has been posted. Accordingly, COG assumes no liability for any action or inaction regarding transmissions, communications, or content provided by any Authorized User or third party. COG has no liability or responsibility to anyone for performance or nonperformance of the activities described in this section.
These content standards apply to any and all Contributions of Authorized Users to the COG Website and use of its interactive services. Contributions of Authorized Users must in their entirety comply with all applicable federal, state, local, and international laws and regulations. Without limiting the foregoing, the Contributions of Authorized Users must not:
· Contain any material that is defamatory, obscene, indecent, abusive, offensive, harassing, violent, hateful, inflammatory, or otherwise objectionable.
· Promote sexually explicit or pornographic material, violence, or discrimination based on race, sex, religion, nationality, disability, sexual orientation, or age.
· Infringe any patent, trademark, trade secret, copyright, or other intellectual property or other rights of any other person.
· Be likely to deceive any person.
· Promote any illegal activity, or advocate, promote, or assist any unlawful act.
· Cause annoyance, inconvenience, or needless anxiety or be likely to upset, embarrass, alarm, or annoy any other person.
· Impersonate any person, or misrepresent Authorized User identity or affiliation with any person or organization.
· Involve commercial activities or sales, such as contests, sweepstakes, and other sales promotions, barter, or advertising.
· Give the impression that they emanate from or are endorsed by COG or any other person or entity, if this is not the case.
· Use COG Data for the purposes of buying, trading, investing, or otherwise negotiating for investments, stock or simple purchases or sales related to organizations disclosed in the COG Website or study results presented therein.
If an Authorized User believes that any content violates COG copyright, the Authorized User is encouraged to contact COG for instructions on sending a notice of copyright infringement. COG reserves the right to terminate the status of an Authorized User who infringes on COG copyright.
Reliance on Information Posted
The information presented on or through the COG Website is made available for research purposes. COG does not warrant the accuracy, completeness, or usefulness of this information. Any reliance placed on such information is strictly at the risk of the Authorized User. COG disclaims all liability and responsibility arising from any reliance placed on such materials by the Authorized Users, or by anyone who may be informed of any of its contents.
The COG Website may include content provided by third parties, including materials provided by other users, third-party licensors, study sponsors, syndicators, aggregators, and/or reporting and monitoring services. All statements and/or opinions expressed in these materials, and all articles and responses to questions and other content, other than the content provided by COG, are solely the opinions and the responsibility of the person or entity providing those materials. Such materials do not necessarily reflect the opinion of COG. COG is not responsible, or liable to an Authorized User or any third party, including a Member Institution and/or Affiliate, for the content or accuracy of any materials provided by any third parties.
Changes to the COG Website
COG updates the content on the COG Website continuously. Specific content may, however, not necessarily provide complete or up-to-date information. Any of the material on the COG Website may be out of date at any given time, and COG holds no obligation to update such material.
Linking to the COG Website and Social Media Features
COG may allow links to the COG Website provided the time, place, and manner of presentation is fair and legal and does not damage the reputation of COG or take advantage of it; a link must not be established in such a way as to suggest any form of association, approval, or endorsement by COG without COG’s express consent, except to the extent accommodated in accordance with Member Institution status.
The COG Website may provide certain social media features that enable an Authorized User to:
· Link from certain COG-approved third-party websites to certain content on the COG Website.
· Send emails or other communications with certain content, or links to certain content, on the COG Website.
· Cause limited portions of content on the COG Website to be displayed or appear to be displayed on an Authorized User’s own or certain third-party websites.
An Authorized User may use the above-noted features subject to the below restrictions, and solely with respect to the content they are displayed with, and otherwise in accordance with any additional terms and conditions COG may provide with respect to such features. Thus, an Authorized User must not:
· Establish a link from any website that is not owned or controlled by the Member Institution and/or Affiliate of the Authorized User.
· Cause the COG Website or portions of it to be displayed on, or appear to be displayed by, any other site, for example, framing, deep linking, or in-line linking.
· Link to any non-approved websites, and otherwise link only through pages facilitated through the COG Website homepage.
Authorized Users agree to cooperate with COG in causing any unauthorized framing or linking immediately to stop. COG reserves the right to withdraw linking permission without notice.
COG may disable all or any social media features and any links at any time without notice in its discretion. COG will bear no responsibility for the loss of any Authorized User content or data should COG have to disable all or any social media features and links.
Links from the COG Website
If the COG Website contains links to other sites and resources provided by third parties, these links are provided to Authorized Users for convenience only. COG has no control over the contents of those sites or resources, and accepts no responsibility for them or for any loss or damage that may arise from use of them by Authorized Users. An Authorized User who may access any of the third-party websites linked to the COG Website, assumes the individual risk in doing so and is subject to the terms and conditions of use for such websites.
Unauthorized Use or Disclosure
Compliance with Law
Each Authorized User, including related Member Institution, agrees to comply (and require each of its Affiliates to comply) with any ethical obligation or obligation of confidentiality imposed as a result of applicable law, regulation, or governmental policy, obligations of informed consent, IRB rule or policy, or other requirement designed to protect the rights of human subjects who participate in research. Nothing in this Agreement is intended to minimize the privacy rights of human subjects and each Authorized User agrees to notify COG (and/or the Public Health Institute) on an ongoing basis if issues arise relating to the same.
Right of Injunctive Relief
NEITHER COG NOR THE PUBLIC HEALTH INSTITUTE WARRANT OR REPRESENT THAT THE COG DATA AND THE RESEARCH DATABASE ARE ERROR-FREE OR FREE OF HARMFUL COMPUTER CODE OR TECHNOLOGY SUCH AS WORMS OR TROJAN HORSES. ACCORDINGLY, THE MEMBER INSTITUTION AND/OR AFFILIATE ASSOCIATED WITH AN AUTHORIZED USER AGREES THAT NEITHER COG NOR THE PUBLIC HEALTH INSTITUTE SHALL BE LIABLE TO THE MEMBER INSTITUTION AND/OR AFFILIATE (OR ANY INSTITUTION AFFILIATE, OFFICER, OR SUCCESSOR THEREOF) FOR ANY LIABILITY, LOSS, EXPENSE (INCLUDING REASONABLE ATTORNEY’S FEES), OR CLAIMS FOR INJURY OR DAMAGES ARISING OUT OF OR BASED ON A TRANSMISSION, DOWNLOADING, PROPAGATION, OR USE BY THE MEMBER INSTITUTION AND/OR AFFILIATE, OR THE AUTHORIZED USERS OF EITHER.
Comments and Concerns
The COG Website is owned and operated by COG. Feedback, comments, requests for technical support, and other communications relating to the COG Website should be directed to:COGPrivacy@childrensoncolocygroup.org.