SMART-TRIAL strives to achieve a high degree of data and communication security as sensitive information may be stored in relation to the usage of SMART-TRIAL. To ensure all stakeholders of SMART-TRIAL that efforts have been implemented, this document clarifies which measures have been taken in design and production of SMART-TRIAL - in relation to data-storage, -backup, -security, -privacy, and international and country-specific regulations which have to be complied with, when handling personal identifiable information or other sensitive healthcare related data
This document applies to all actors and users of the SMART-TRIAL system as a whole. SMART-TRIAL is owned, developed, and maintained by SMART-TRIAL ApS (VAT NR: DK35139710). SMART-TRIAL ApS serves as an independent legal identity and is the copyright owner of SMART-TRIAL.
All users of SMART-TRIAL are direct customers of SMART-TRIAL ApS and shall therefore only be bound to usage, license, and data processing agreements with SMART-TRIAL ApS.
May: Used to describe a permissible way to achieve compliance
PII: Personal Identifiable Information
Shall or must: Compliance is mandatory
Should: Compliance is recommended, but not mandatory
SOP: Standard Operating Procedure
User/customer: Used to describe a person that has a user account in SMART-TRIAL
SMART-TRIAL has a set of standard operation procedures (SOP) which state how information security shall be managed within SMART-TRIAL ApS. This covers not only general internal information security, but product specific information security as well, such as those regarding SMART-TRIAL and SMART-TRIAL’s customers.
The SOPs specify how all employees and subcontractors should conform with information security and data management at SMART-TRIAL ApS, and is influenced by the ISO27001 and SO27002
SMART-TRIAL ApS has appointed a Data Protection Officer which handles all data protection issues and queries regarding SMART-TRIAL ApS. This is according to the EU regulation 2016/679, required by SMART-TRIAL ApS. The data protection officer can be contacted via e-mail. Any enquiries regarding data protection, and data policy, will be handled and responded to in a timely manner, according to the specifics noted in the 2016/679 EU regulation.
All personnel that have access to, or administrate production environments, which contain PII, are educated in the concepts of information security and relevant technologies, and must adhere to all relevant SOPs within SMART-TRIAL ApS. Only employees who have been certified by SMART-TRIAL's CEO, can gain access to perform administrative operations on production environments for SMART-TRIAL (e.g. verifying backups).
Access to any security critical systems of SMART-TRIAL, such as databases management systems, servers, or other production environment technologies, are only provided to specific employees on a need-to-know basis. Access to each of these systems is handled in coherence with the internal information security management SOPs. A record of system access is kept for compliance purposes and reviewed accordingly
All production systems and servers are monitored for malicious activity and maintained accordingly – both manually and via automatic monitoring. Access logs to servers, and production service environments are reviewed on a regular basis
SMART-TRIALs quality assurance is based on and in compliance with the PIC/S Guidance, PI-011-3 Good Practices for Computerised Systems in Regulated “GxP” Environments, and the software validation process is based on IEC 62304. SMART-TRIAL simplifies regulatory compliance for ISO 14155 (GCP), FDA 21 CFR Part 11, GDPR, and HIPAA by offering ready-to-use QA templates, system modules, and guidance documents.
Development and software programming is performed according to SMART-TRIAL ApS quality management system standards. Code styles used are in coherence with Google’s coding styles and all development follows specific workflow guidelines. All production code is subject to regular code inspection/review and testing
Microsoft is the only hosting service provider for SMART-TRIAL. Microsoft are bound by a GDPR compliant data processing agreement with SMART-TRIAL ApS (MicrosoftProducts and Services Data Protection Addendum) which includes the latest standard contractual clauses (SCCs) and prohibits Microsoft to provide any information or data in relation to SMART-TRIAL to third parties unless specifically authorized to do so.
All data, and production environments for SMART-TRIAL are stored and hosted on SMART-TRIAL ApS’s private and secure hosting services within Microsoft Azure. No third party has access to any data on SMART-TRIAL ApS hosting services .
All data in relation to a specific study created within SMART-TRIAL is owned by the study creator/owner and its participants. Data can be delivered in raw format to the study owner by request at any time. study creator/owner can export all relevant data from within the system using the available data export functions.
All other data stored with Microsoft Azure in relation to SMART-TRIAL is owned by SMART-TRIAL ApS, and any government and law enforcement request to access data is performed in coherence with the appropriate legal process – see  and  for more details.
SMART-TRIAL ApS has designed SMART-TRIAL to adhere to a “No-Direct-Data Access Policy”. This means that SMART-TRIAL cannot be used by SMART-TRIAL ApS administrative staff to access customer data without direct permissions given from data-owners (study owners). In any case, a study owner is always responsible for giving out permission to those users who should be able to view/access their data, which can only be done via the platform itself.
As long as SMART-TRIAL ApS has legal ownership of SMART-TRIAL and its production environments and hosting services SMART-TRIAL customers shall be able to access their data via the SMART-TRIAL platform. Only upon special requests can data be acquired directly from SMART-TRIAL ApS, i.e. if data cannot be acquired from SMART-TRIAL directly.
Microsoft will never reveal any data directly to SMART-TRIAL customers or other third parties  without explicit permission from SMART-TRIAL ApS, as long as SMART-TRIAL ApS is an established legal identity.
In the case of where SMART-TRIAL ApS is no longer an established legal identity, or a business organization of any sort which allows SMART-TRIAL ApS to maintain or withhold SMART-TRIAL and its data as described within this statement and SMART-TRIAL license agreements, the following procedures will unfold.
However, these procedures do not unfold if another legal identity accepts, or overtakes the legal data responsibilities of SMART-TRIAL ApS in regards to SMART-TRIAL, such as in the case of a merger and acquisition, and its customer’s data – in this case, all SMART-TRIAL customers will be informed beforehand.
The Microsoft Azure platform itself and Microsoft data centers are certified with a broad set of international and industry-specific standards such as: ISO/IEC:27001, ISO/IEC:27018, FedRAMP, and SOC 1 and SOC 2. Microsoft Azure cloud services also meet regional and country-specific standards and contractual commitments, including the EU Model Clauses (i.e. EU Data Protection Directive 95/46/EC), UK G-Cloud. In addition, rigorous third-party audits, such as by the British Standards Institution and Deloitte, validate the adherence of the Azure cloud services to the strict requirements these standards mandate. The complete list of compliance standards, certificates, third party audit reports, and white papers for Microsoft Azure its datacenters can be found from .
All data in relation to SMART-TRIAL is stored on secured Microsoft Azure hardware located in the European Union . Due to security measures, and conformity regulations with international and country-specific standards, Microsoft does not disclose the details of a physical addresses to its data centers to any of its customers, including SMART-TRIAL ApS. Therefore, SMART-TRIAL ApS cannot, and will not, require Microsoft to disclose the physical location in more detail. However, SMART-TRIAL and Microsoft Azure ensure that all data is stored using geo-redundant storage (GRS) where data is replicated synchronously three times in the primary region (Ireland) and also in a secondary region (the Netherlands).
SMART-TRIAL ApS highly values its customers’ data privacy and security, and therefore highlights that information such as a physical street address or housing of data servers is non-relevant in this case of data privacy and security and will only be regarded as a security-risk if revealed.
Since SMART-TRIAL ApS is a legal identity within the kingdom of Denmark, SMART-TRIAL ApS must conform to Danish and EU legislation and regulations regarding data privacy and data processing. According to both the Danish data-protection agency (Datatilsynet)  and the Danish law order for security and protection of PII, which are handled by public legal identities (sikkerhedsbekendtgørelsen) , it is NOT required by data processors, such as SMART-TRIAL ApS, to reveal more detailed information of a physical addresses of data service providers and data servers, other than country or city/state specifics.
It is therefore up to the data processor, to decide if customers are required to be informed of such information or not. If required by law, for any SMART-TRIAL customer to access his data from a physical address, without having to acquire it via SMART-TRIAL ApS, Microsoft will accept law enforcement request to access customer data and will be handled as described in  and .
The services and interfaces of SMART-TRIAL follow the hosting provider’s availability and uptime guarantees. This means that all users of SMART-TRIAL, apart from those located in Asian countries and Russia, can receive and process requests at minimum 99.9 % of the time (usually around 100%), as Microsoft Azure promises a server uptime of minimum 99.9 % per . SMART-TRIAL ApS strives to keep uptime of all SMART-TRIAL services as high as possible, and are notified continuously if any downtime is experienced. Uptime is defined as the amount of time the SMART-TRIAL system is up and running and available for use. Uptime is measured per month, and is calculated from the following formula: % uptime each month = 100 x ((24 x number of days in the month) – total downtime in month) / (24 x number of days in the month).
Downtime is defined as the number of hours the SMART-TRIAL system is not up and running and available for use during one month. However, the following conditions do not represent the system being out of reach, and thus not included in the definition of downtime:
Per definition, all service windows are included in the uptime guarantee, if notified at a minimum of 3 days in advance. In cases that are to be classified as emergencies, which require an extraordinary service window, services or maintenance windows are announced at least 24 hours in advance.
Emergency service windows are only announced in cases where security issues are discovered.
SMART-TRIAL makes use of multiple services to serve/store data from users, such that if any service becomes unavailable, the system will be able to re-initiate operation without serious inconvenience, or loss of any data. SMART-TRIAL utilises a specific replica-set technology, to distribute data between secure servers that enables consistent and high availability of all data stored in SMART-TRIAL.
If a server becomes unavailable, the SMART-TRIAL personnel is immediately notified such that a resolution can be found as quickly as possible. Server failures should not affect performance of SMART-TRIAL interfaces and users should in most cases not be affected by any server failures - see 3.1 and 3.2 In any case, SMART-TRIAL personnel will strive to return all services back to normal within at least 24 hours
Backup of all data stored in databases is performed regularly such that data can be restored in case of any critical failures. Backup is performed by multiple machines, where data is continuously replicated multiple times 24/7/365. In addition, continuous file system backups are made on all data and stored separately. Backups have however a maximum lifetime of 14 days. Due to the fact that if any study data is requested to be deleted by a SMART-TRIAL customer, backup data must be deleted as well. All backup data, and backup to any services used by SMART-TRIAL is kept within the European Union as previous mentioned in 2.7 and documented and described by Microsoft in  and . All data is backed up using geo-redundant-storage (GRS) using the primary region North Europe (Ireland) and secondary region West Europe (Netherlands)
For every new SMART-TRIAL version release, all users of SMART-TRIAL are informed, with information on changes and/or feature updates. In most cases, a version release should not affect users in critical ways. If such critical releases are required, all users will be informed of the specifics timely, to prepare for any inconvenience which they might experience.
SMART-TRIAL has a policy and a plan in place which covers how business continuity and disaster recovery is handled. SMART-TRIAL's management conducts testing and review of these objectives continuously, such as on re-location of workspace and communication channels, backup recovery and deployment of production environments.
Microsoft Azure provides threat management in relation to services hosted by Azure, and as such SMART-TRIAL and the underlying network used to link SMART-TRIAL services together is subject to threat management as described in , hereunder techniques for DDoS prevention, intrusion detection, injection preventions, and anti-malware. Once a year SMART-TRIAL hires an external security advisory company to conduct a penetration test on the SMART-TRIAL platform and its infrastructure. SMART-TRIAL customers can request a copy of the penetration test report.
The servers running SMART-TRIAL services are locked on all ports except for the ones used by the system internally, and only accepts requests from the internal service IP addresses. The public web-interface servers only accepts connections on port 443 (HTTPS) and port 80 (HTTP), however access on HTTP will always redirect to HTTPS in order to ensure full network encryption between all services and SMART-TRIAL customers and clients.
All new system functionality and design changes are verified and validated per SMART-TRIAL ApS SOP (system functionality and security testing) in a separate testing environment fully separated from the SMART-TRIAL production environment before being made available to the public production environments.
Access to any services hosted by Microsoft Azure is subject to audit logging  and as such all attempts to access any servers used SMART-TRIAL are logged for security analysis and monitoring. Any server failure is automatically reported to the SMART-TRIAL personnel as well.
SMART-TRIAL staff work from a physically secure location, where appropriate network and physical security measurements have been implemented to minimize security risks on production environments of SMART-TRIAL. SMART-TRIAL staff that have to interact with production environments use only computer equipment that has been certified by management to connect with any work environments. Physical location and network are reviewed by management on a continuous basis to minimize any vulnerability or unauthorized access. Access to a physical office location and/or internal office network, does not provide any access to product or testing environments of SMART-TRIAL.
SMART-TRIAL implements both contractual and technical safeguards, as recommended by the EDPB (European Data Protection Board), to minimise unlawful access and processing of personal data, especially by third-country sub-processors. Additional technical safeguards include for example storage of encryption keys separately from application and data hosting services, using FIPS 140-2 Level 3 validated HSMs (Hardware Security Modules). Contractual safeguards include the use of the latest EU SCC and DPA template from the EU in SMART-TRIAL's online data processing term and the use of EU SCC with our sub-processors, while also limiting access to personal data using industry best-practice access security and encryption mechanisms.
All communication between users of SMART-TRIAL and the system is encrypted with use of the Secure Socket Layer (SSL) and Transport Layer Security (TLS) technologies, which ensures that ALL data sent between clients and the SMART-TRIAL system is obscured from outside parties. Furthermore, SSL and TLS makes use of data encryption and server verification, which implies that data only can be interpreted by the intended parties.
The SMART-TRIAL system is split into different entities to ensure availability. All communication between the internal entities of SMART-TRIAL is performed via secure SSL/TLS connections as well, such that data may not be interpreted by third parties during internal system communication.
All encryption standard for SMART-TRIAL, for both communication and data encryption, is at minimum AES-256 (i.e. the AES algorithm using 256 bit keys).
To collect and view data, or access a study in SMART-TRIAL users must create a user account with an associated strong password, which shall be used to authenticate with the system. Users shall provide the following information and accept usage terms before being able to authenticate against the system.
E-mail address is used as a unique identifier for user profiles, as well as username to login. Mobile number and password are used to validate authentication of each user profile. In addition to these information, the following are optional and can be required collaborators by SOP in individual studies.
To perform any security critical actions within the system, a user must be authenticated. SMART-TRIAL implements two-step authentication for every log in, i.e. users must log in to the system using their created credentials and confirm their authentication with a unique one-time code sent to their mobile phone or e-mail address. In addition, user can also ask the system to call them directly for confirming the one-time code. On successful authentication, SMART-TRIAL creates a unique user-session that is used to identify the authenticated user. The session contains no information about the user’s password or other personal identifiable information and is valid for a limited time only. When the session expires, a user can choose to prolong his session by re-authenticating against the system - this is however only possible for 15 minutes. If a user does not prolong his session within this 15-minute time frame, the system automatically disables the user session and logs him out of the system, requiring him to perform a complete two step authentication against the system.
SMART-TRIAL does not accept any interface or data requests that do not have a valid session.
SMART-TRIAL requires user passwords to conform with a high level password security to limit the possibility of brute-force attacks. A user password is stored with individual salt values and hashed multiple times. Passwords cannot be recovered in clear text and do require users to create new passwords in case of a lost password.
SMART-TRIAL’s password policy is strict, and every user must create a password that must consist of at least all of the following
SMART-TRIAL is protected against user profile brute force attacks, by utilizing two-step verification as described in 5.3 “soft-lockout”, and “hard lockout”. “Soft-lockout” enables captcha verification to be performed after 3 unsuccessful login attempts and user profile “lockout” is activated after 5 unsuccessful login attempts. This requires a user to contact SMART-TRIAL support directly for unlocking the user profile. All unsuccessful login attempts are logged – see 5.7
Even though security measures are employed in regards to passwords, users are still responsible for defining their own secure passwords, and not sharing their passwords with anyone. SMART-TRIAL ApS recommends that individual organizations confirm with the ISO/IEC 27001 and 27002 standards for information security management. SMART-TRIAL does not require users to change their passwords, but as a recommendation, they should be changed regularly for security measures.
All non-successful authentication and unauthorized requests tries, are logged within the system and only accessible by SMART-TRIAL system administrators. These access logs are reviewed regularly as described in 1.4. If suspicious activity is noted, the specific user profiles will be analyzed in detail and the owner of the user profile will be contacted.
SMART-TRIAL makes use of permission based access to every data created/collected in relation to studies. Only the owner of a study, and users that have been given explicit access by the study owner via the system, may gain access to the study’s data. Each study owner is therefore solely responsible for keeping track of all collaborators (i.e. users that have been given any type of access to the study), their roles, and permissions. All manipulation of user permissions to studies is logged in the study audit log (see 5.12).
SMART-TRIAL administrator/support users have no access to any of the studies created within the system. Administrative users can therefore only gain access to a study and its data, if a study owner gives an administrative user profile explicit access to their study.
Specific sensitive data attributes stored in relation to user profiles, subject profiles, and form answers are stored in an hashed format, and may only be decrypted with the corresponding encryption key and system specific methods. The encryption keys are stored securely and only available to the system internally and cannot be used by any administrative staff or other users solely to decrypt information in case of security breach – due to the “No-Direct-Access Data Policy” see 2.4.
SMART-TRIAL stores study specific data in separate databases, such that all data for individual studies are clearly separated. Each study database is fully encrypted and only accessible by the study owner/creator via SMART-TRIAL and the SMART-TRIAL system internally. This allows for clear data separation and ensures that cross-querying between studies is not possible.
SMART-TRIAL allows users to export study data (such as form answers, medication data, AE/SAE's etc.) at any time for statistical purposes – as long as users have permissions to do so. This functionality is separately protected and requires two-step verification. A user must request and verify a one-time password via SMS before being able to export data from the system. As soon as any data has been exported from SMART-TRIAL, the corresponding user is responsible for complying with country-specific laws and regulations of PII. SMART-TRIAL ApS cannot be held reliable in any way, if exported data is mistreated by users which exported the data. SMART-TRIAL ApS is solely responsible for secure storage of PII data, as long as the data is kept within SMART-TRIAL.
All critical actions performed by users of SMART-TRIAL are logged both in relation to general operations (e.g. user creation/edit) and study specific operations. study owners may review operations performed on data in relation to their own study and even export specific audit/transaction logs. Audit logging ensures that all operations performed by users can be traced. The study specific audit/transaction logs contain information about the following:
System specific logs are kept indefinitely and always accessible by SMART-TRIAL administrative staff.
Study specific logs are kept within the specific study databases until the study owner explicit requests for study data (database) to be deleted. However, study owners can choose not to delete their study from within SMART-TRIAL.
Study data and its logs are kept indefinitely and securely within SMART-TRIAL, as long as study owner does not explicitly request for data deletion (database deletion).
When a study owner requests for a study to be deleted, SMART-TRIAL registers a “delete date” for the study - which shall be 10 days after delete request is made. After 10 days, the study specific database is deleted completely from all SMART-TRIAL production services and study owner is informed of successful deletion. Any backups of the study data are kept for maximum 7 days after the database has been deleted (see why in 3.4). Afterwards, project data cannot be recovered in ANY way. SMART-TRIAL ApS has verified and validated this deletion method for every release.
Usage of SMART-TRAIL should always be performed through a supported browser. The supported browsers are:
Due to performance and security issues it’s recommended that users avoid the use of Internet Explorer and choose any of the other supported browsers.
It’s recommend to use the newest version of any of the above browsers, since they will contain the most up-to-date security patches.
Data collection in relation to a study conducted with SMART-TRIAL is secured by only allowing users with explicit permission in a study to complete forms for a subject. Furthermore, forms that should be filled out by subjects participating in a study can only be done by following a random generated unique link sent to each subject via e-mail or SMS. E-mail/mobile verification can also be enabled on process level in relation to subject form fill out, to further validate subject identity.
SMART-TRIAL ApS incorporates the latest technologies for secure computing and data storage in cooperation with Microsoft Azure. However, data transmission over the internet and data storage can never be guaranteed 100% secure. As such, if a security breach should occur, the affected customers of SMART-TRIAL will be informed via personal e-mail sent to each individual user/customer. If customers do not respond to this formal notice within 3 days, contact will be taken via telephone.
A formal notice will contain the type of security breach the system was subject to and what measures have been taken to ensure minimal data breach. In addition, SMART-TRIAL ApS will inform all users of which actions to take to minimize any risk of inconvenience.
All security breach incidents are reported and documented in a standardized way, as described in SMART-TRIAL ApS internal security management procedures.
For a closer explanation of which aspects of the system are outside the responsibility area of SMART-TRIAL please contact email@example.com.
If you have any questions regarding security, data privacy, technical documentation, validation, or SOPs, you are always welcome to contact us via: firstname.lastname@example.org.