SITS International (“SITS”, “us”, “we”, or “our”) manages the SITS Registry platform db.sitsinternational.org (the “SITS Registry”), the SITS ICH/IVH Registry platform registry.sitsinternational.org (the “ICH Registry), the website sitsinternational.org (the “SITS Website”), and SITS Services, of which these Terms and Conditions apply to.
Summary of main changes to SITS Terms and conditions per March 2023:
- Confidentiality of documents, material, knowledge, and information, under section Obligations,
- Notify SITS on suspicion regarding data breach under section General.
- Data entered in SITS cannot be removed under section LC must also adhere to
- Data is shared for scientific research and quality purpose only under section Processing of personal data.
- Personal information in SITS
Local User (LU)
Obligations as LU
- You must ensure that all consecutive acute stroke patients that receive care at the centre, must be registered depending on the data entry form(s) the centre has chosen, e.g. if your centre use only IV thrombolysis (IVT) data entry form then you must register all IVT treated patients in your centre – this is fundamental for the interpretation of safety data.
- You must follow good clinical practices (GCP) with regards to patient data handling.
- Your account is personal and shall not be shared or used by anyone else.
- You are responsible to keep your personal information in your user account updated.
- You are responsible to inform SITS Coordination Office whenever your function at your hospital changes in a way so that your user account is no longer needed as intended for you and the task you performed in your SITS centre, e.g. due to termination, retirement or change of duties.
- Acknowledgement of SITS when data collected through the SITS Registry is presented at local, national and/or global context, e.g. presentation of data collected through SITS on conferences, webinars, meeting etc.
- Confidentiality of documents, material, knowledge, and information: SITS can share confidential material, information, and documents with users of the SITS Registry that are not public or published yet (e.g. CRFs, manuscripts, agreements). These documents, material, knowledge, and information are used for network and scientific purposes only and cannot be shared with third parties without SITS permission.
Rights as LU
- All patient data entered by the centre is owned by the centre, and the centre can use these data for any purpose (e.g. scientific research and quality) without any approval from the SITS International.
- As an active centre in SITS, you have the right to submit a project proposal to the SITS Scientific Committee for the use of national or international data.
General for all users
SITS urges you to not, including assist or enable, other SITS User(s) or external personnel in the SITS Registry to:
- Breach or circumvent any applicable laws or regulations, this document, agreements with third-parties, third-party rights, or our other Policies or Standard operating procedures;
- Discriminate against, or harass anyone based on race, national origin, religion, gender, gender identity, physical or mental disability, medical condition, marital status, age, sexual orientation, or otherwise engage in any violent, harmful, abusive, or disruptive behaviour.
- Use, display, mirror or frame the SITS Registry or Collective Content, or any individual element within the SITS Registry, SITS name, any Organisational trademark, logo or other proprietary information, or the layout and design of any page or form contained on a page in the SITS Registry, without the consent of SITS;
- Use any robots, spider, crawler, scraper or other automated means or processes to access, collect data or other content from, or otherwise interact with the SITS Registry for any purpose;
- Avoid, bypass, remove, deactivate, impair, descramble, or otherwise attempt to circumvent any technological measure implemented by SITS, any provider of SITS, or any other third party, to protect the SITS Registry;
- Attempt to decipher, decompile, disassemble or reverse engineer any of the software used to provide the SITS Registry;
- Take any action that damages or adversely affects, or could damage or adversely affect the performance or proper functioning of the SITS Registry;
- Violate or infringe anyone else’s rights or otherwise cause harm to anyone within SITS International and/or its users.
- Immediately and without delay notify SITS International on discovery or in suspicion of personal data breach.
Local Coordinator (LC)
- Same obligations and rights as Local User (LU), plus the following:
Obligations as LC:
- The person who submits the application to serve as a Centre/Local Coordinator (LC) for SITS must be a medical doctor authorised by the medical head of the department responsible for the stroke unit.
- LC agrees to participate in the ongoing data collection in SITS Registry for retrospective analysis and is responsible to assure that applicable approvals (if needed) for using the SITS Registry are in place according to local regulations and ethical guidelines (such as ethical committee, data protection approvals).
- LC is responsible to ensure that the patient is informed about the data recorded in the SITS Registry and the patient has the right to remove data his/her data from the registry upon request.
- LC must accept source data monitoring by external representatives for SITS.
- LC must accept that individual patient data (pseudonymised) recorded in the SITS Registry from the centre is also shared with national and international scientific collaborators.
- LC must accept collaboration to evaluate any suspected treatment complication, e.g. provide information from patient files about results from examination etc.
- If you are no longer responsible for your centre as LC, you are advised to inform the head of department to find a replacement of the role.
- LC is primarily responsible and must ensure that all data entry (patient data, centre information) is correct and complete.
- LC must ensure that the data is inputted on a regular basis.
- If patient recruitment is terminated in the SITS Registry, LC is kindly requested to report this to the SITS Coordination Office.
- LC must ensure that inactive user accounts in the centre are disabled.
- LC contact information (name, country, hospital information, email, centre information) might be shared with others in the SITS network and, for scientific purposes only.
- LC may delegate administrative tasks to an associate Local Coordinator (aLC) after informing SITS.
- LC must accept that data entered by the centre in the SITS Registry is an integrated part of the SITS global dataset and is used for scientific publications. Data already entered cannot be removed even if the centre stops using the SITS Registry.
Processing of personal data
Data is shared for scientific research and quality purpose only.
Last updated of SITS Terms and Conditions was 2023-03-08.