Background: In the last few years, biobanks have developed as important resources for the progress in human targeted therapy. One of the essential pre-conditions for the acquisition and storage of human biological samples for multiple medical research purposes is the informed (broad) consent form (Recital 33) signed by the donor after comprehensive written and oral information, as once more stated in the EUGDPR (Art. 7 and 9), to be applied since 25.05.2018. However, in case of broad consent the unpredictability of the future use needs compensation by additional procedural methods as a pre-condition for the legal validity of the donor’s consent (1). Methods: Commonly, the informed consent for research projects using human biosamples covers only defined specific research objectives. From 2012 to 2014, the biobanking Task Force of the Working Party of the German Medical Ethics-Committees (WP-GMEC) has developed a nation-wide consented template for the broad use of human biosamples and related data (2). In November 2018, the same Task Force issued recommendations on the application of the new GDPR, which in November 2019 have been integrated into the current broad consent template (3). Results. Bound by material transfer or data access agreements, researchers using biosamples and/or data collected under a broad consent must be kept from any attempt of identifying individuals, of whom samples and/or data have been received. Most important, since implementation of the GDPR human biosamples and related data must be released only to projects and institutions from countries applying appropriate data protection safeguards (GDPR Articles 44 to 50). The transfer of human biosamples and/or data to non-EU or non-EEA countries may only take place, if the respective third country ensures a level of privacy protection that adheres to the EU Regulation 2016-679. With the implementation of the GDPR, either the application of formal safeguards (as listed in the GDPR), or an explicit information on the potential transfer-risks and an explicit opt-in for any transfer of biosamples and/or related data in countries not fulfilling the GDPR-criteria (as judged by the EU-commission) is mandatory. If the country concerned fails to ensure sufficient privacy protection, samples and/or data must be anonymized prior to transfer. In any case, the pseudonymization keys must remain in the EU (1). Independent ethics committees are of particular importance to assess whether GDPR-conform workflows have been implemented both, in human research biobanks and in research projects making use of broad consent samples (1). In addition, the donors have to be informed unambiguously on the broad scope of the intended use of their biosamples and related data if compatible with the medical research purpose or topic (e.g., cancer research, cardiovascular research; Recital 33). Research biobanks are recommended to reciprocate by making processes transparent (GDPR Art. 12) and intensifying participant’s (Recital 33) and public involvement (1). Conclusion. The 2019 updated nation-wide applicable master template for the broad use of human biosamples (and related data) aims at fulfilling both the current WMA-recommendations for human biobanks and the new donor rights and standards prescribed by the EU-GDPR. The template furnishes a framework that permits biobanks to store and use human biosamples in principle without restrictions regarding the scope of biomedical research. It appears suited to serve as a model for a harmonized European-wide consent facilitating broad use of human biosamples for cross-border biomedical research.

Background: In the last few years, biobanks have developed as important resources for the progress in human targeted therapy. One of the essential pre-conditions for the acquisition and storage of human biological samples for multiple medical research purposes is the informed (broad) consent form (Recital 33) signed by the donor after comprehensive written and oral information, as once more stated in the EUGDPR (Art. 7 and 9), to be applied since 25.05.2018. However, in case of broad consent the unpredictability of the future use needs compensation by additional procedural methods as a pre-condition for the legal validity of the donor’s consent (1). Methods: Commonly, the informed consent for research projects using human biosamples covers only defined specific research objectives. From 2012 to 2014, the biobanking Task Force of the Working Party of the German Medical Ethics-Committees (WP-GMEC) has developed a nation-wide consented template for the broad use of human biosamples and related data (2). In November 2018, the same Task Force issued recommendations on the application of the new GDPR, which in November 2019 have been integrated into the current broad consent template (3). Results. Bound by material transfer or data access agreements, researchers using biosamples and/or data collected under a broad consent must be kept from any attempt of identifying individuals, of whom samples and/or data have been received. Most important, since implementation of the GDPR human biosamples and related data must be released only to projects and institutions from countries applying appropriate data protection safeguards (GDPR Articles 44 to 50). The transfer of human biosamples and/or data to non-EU or non-EEA countries may only take place, if the respective third country ensures a level of privacy protection that adheres to the EU Regulation 2016-679. With the implementation of the GDPR, either the application of formal safeguards (as listed in the GDPR), or an explicit information on the potential transfer-risks and an explicit opt-in for any transfer of biosamples and/or related data in countries not fulfilling the GDPR-criteria (as judged by the EU-commission) is mandatory. If the country concerned fails to ensure sufficient privacy protection, samples and/or data must be anonymized prior to transfer. In any case, the pseudonymization keys must remain in the EU (1). Independent ethics committees are of particular importance to assess whether GDPR-conform workflows have been implemented both, in human research biobanks and in research projects making use of broad consent samples (1). In addition, the donors have to be informed unambiguously on the broad scope of the intended use of their biosamples and related data if compatible with the medical research purpose or topic (e.g., cancer research, cardiovascular research; Recital 33). Research biobanks are recommended to reciprocate by making processes transparent (GDPR Art. 12) and intensifying participant’s (Recital 33) and public involvement (1). Conclusion. The 2019 updated nation-wide applicable master template for the broad use of human biosamples (and related data) aims at fulfilling both the current WMA-recommendations for human biobanks and the new donor rights and standards prescribed by the EU-GDPR. The template furnishes a framework that permits biobanks to store and use human biosamples in principle without restrictions regarding the scope of biomedical research. It appears suited to serve as a model for a harmonized European-wide consent facilitating broad use of human biosamples for cross-border biomedical research.

Background: In the last few years, biobanks have developed as important resources for the progress in human targeted therapy. One of the essential pre-conditions for the acquisition and storage of human biological samples for multiple medical research purposes is the informed (broad) consent form (Recital 33) signed by the donor after comprehensive written and oral information, as once more stated in the EUGDPR (Art. 7 and 9), to be applied since 25.05.2018. However, in case of broad consent the unpredictability of the future use needs compensation by additional procedural methods as a pre-condition for the legal validity of the donor’s consent (1). Methods: Commonly, the informed consent for research projects using human biosamples covers only defined specific research objectives. From 2012 to 2014, the biobanking Task Force of the Working Party of the German Medical Ethics-Committees (WP-GMEC) has developed a nation-wide consented template for the broad use of human biosamples and related data (2). In November 2018, the same Task Force issued recommendations on the application of the new GDPR, which in November 2019 have been integrated into the current broad consent template (3). Results. Bound by material transfer or data access agreements, researchers using biosamples and/or data collected under a broad consent must be kept from any attempt of identifying individuals, of whom samples and/or data have been received. Most important, since implementation of the GDPR human biosamples and related data must be released only to projects and institutions from countries applying appropriate data protection safeguards (GDPR Articles 44 to 50). The transfer of human biosamples and/or data to non-EU or non-EEA countries may only take place, if the respective third country ensures a level of privacy protection that adheres to the EU Regulation 2016-679. With the implementation of the GDPR, either the application of formal safeguards (as listed in the GDPR), or an explicit information on the potential transfer-risks and an explicit opt-in for any transfer of biosamples and/or related data in countries not fulfilling the GDPR-criteria (as judged by the EU-commission) is mandatory. If the country concerned fails to ensure sufficient privacy protection, samples and/or data must be anonymized prior to transfer. In any case, the pseudonymization keys must remain in the EU (1). Independent ethics committees are of particular importance to assess whether GDPR-conform workflows have been implemented both, in human research biobanks and in research projects making use of broad consent samples (1). In addition, the donors have to be informed unambiguously on the broad scope of the intended use of their biosamples and related data if compatible with the medical research purpose or topic (e.g., cancer research, cardiovascular research; Recital 33). Research biobanks are recommended to reciprocate by making processes transparent (GDPR Art. 12) and intensifying participant’s (Recital 33) and public involvement (1). Conclusion. The 2019 updated nation-wide applicable master template for the broad use of human biosamples (and related data) aims at fulfilling both the current WMA-recommendations for human biobanks and the new donor rights and standards prescribed by the EU-GDPR. The template furnishes a framework that permits biobanks to store and use human biosamples in principle without restrictions regarding the scope of biomedical research. It appears suited to serve as a model for a harmonized European-wide consent facilitating broad use of human biosamples for cross-border biomedical research.

Qatar Biobank (QBB) is Qatar’s National Repository Centre for biological samples and health information records, promoting medical research aiming to translate the biobank science into evidence-based healthcare interventions., and coordinating an operational plan dedicated to bringing together multidisciplinary stakeholders. QBB biorepository structure is unique by covering Omics data, from whole genome analysis to transcriptomics, epigenomics, proteomics and metabolomics to clinical diagnostic biomarkers and a variety biological sample types to enable medical research of evidencebased healthcare interventions QBB understands that building a successful biobank depends on the willing participation of the public to come forward to contribute. From September 2013 to December 2019, 25570 participants completed the baseline visit; 54% Participants were referred when an abnormal out of range clinical measurement is recorded to the ambulatory care clinic or their own doctor, 81.7 % of them were new cases and 18.3 % were known cases. Most of these referrals were caused by out of range values on related tests for abnormal bone density 44.0 %, dyslipidemia 14.0%, diabetes 13.0%, thyroid function tests 11.0% and osteoporosis 6%.

Qatar Biobank (QBB) is Qatar’s National Repository Centre for biological samples and health information records, promoting medical research aiming to translate the biobank science into evidence-based healthcare interventions., and coordinating an operational plan dedicated to bringing together multidisciplinary stakeholders. QBB biorepository structure is unique by covering Omics data, from whole genome analysis to transcriptomics, epigenomics, proteomics and metabolomics to clinical diagnostic biomarkers and a variety biological sample types to enable medical research of evidencebased healthcare interventions QBB understands that building a successful biobank depends on the willing participation of the public to come forward to contribute. From September 2013 to December 2019, 25570 participants completed the baseline visit; 54% Participants were referred when an abnormal out of range clinical measurement is recorded to the ambulatory care clinic or their own doctor, 81.7 % of them were new cases and 18.3 % were known cases. Most of these referrals were caused by out of range values on related tests for abnormal bone density 44.0 %, dyslipidemia 14.0%, diabetes 13.0%, thyroid function tests 11.0% and osteoporosis 6%.

Qatar Biobank (QBB) is Qatar’s National Repository Centre for biological samples and health information records, promoting medical research aiming to translate the biobank science into evidence-based healthcare interventions., and coordinating an operational plan dedicated to bringing together multidisciplinary stakeholders. QBB biorepository structure is unique by covering Omics data, from whole genome analysis to transcriptomics, epigenomics, proteomics and metabolomics to clinical diagnostic biomarkers and a variety biological sample types to enable medical research of evidencebased healthcare interventions QBB understands that building a successful biobank depends on the willing participation of the public to come forward to contribute. From September 2013 to December 2019, 25570 participants completed the baseline visit; 54% Participants were referred when an abnormal out of range clinical measurement is recorded to the ambulatory care clinic or their own doctor, 81.7 % of them were new cases and 18.3 % were known cases. Most of these referrals were caused by out of range values on related tests for abnormal bone density 44.0 %, dyslipidemia 14.0%, diabetes 13.0%, thyroid function tests 11.0% and osteoporosis 6%.

For over a decade the Swedish U-CAN project has routinely been biobanking liquid biopsies and tissue samples from cancer patients within different diagnosis types [1]. Consenting patients are followed longitudinally and new samples are collected throughout the course of their disease together with extensive clinical data. To date, >11.500 individuals have been included and around 500.000 samples been biobanked in Uppsala. In addition, patients answer surveys regarding lifestyle, health, comorbidities and heredity for cancer. The U-CAN resource is made available for cancer researchers worldwide. For each patient U-CAN needs to record consents, personal data, clinical data (diagnosis, surgery, pathology, oncology, treatments, etc), keep track of the biobanked samples (e.g. blood and tissue), vital status, etc. To keep track of and couple this vast amount of data was a real challenge until 2018 when U-CAN decided to build a comprehensive data tracking system, named “Octopus”, capable of collecting and integrating data from various sources. Octopus is a web-based IT-solution that is centred on the Swedish personal-number system, which provides a common denominator for integrating data between systems. A connection with the Swedish census records provides information on birth-date, gender, county of residence and vital status. Connections with Uppsala Biobank’s LIMS-system provides real-time updates on all liquid biopsies (type of sample, status, number of remaining vials, etc). Clinical data is manually recorded by hospital-staff based on patient records, including notes on the reason why each new sample was taken. Octopus thus enables effective searches for patients, samples and available sample types to be included in various cancer studies, as well as serving as a depository for easy-access clinical data for research purposes. Moreover, Octopus is a pivotal and user-friendly hub for managing the U-CAN staff’s daily work-flow, for tracking patients between clinics, ordering new samples and entering new data. By creating Octopus, UCAN’s data management went from being fragmented and laborious to centralized and easy, while also providing an effective work-management tool for the whole project.

For over a decade the Swedish U-CAN project has routinely been biobanking liquid biopsies and tissue samples from cancer patients within different diagnosis types [1]. Consenting patients are followed longitudinally and new samples are collected throughout the course of their disease together with extensive clinical data. To date, >11.500 individuals have been included and around 500.000 samples been biobanked in Uppsala. In addition, patients answer surveys regarding lifestyle, health, comorbidities and heredity for cancer. The U-CAN resource is made available for cancer researchers worldwide. For each patient U-CAN needs to record consents, personal data, clinical data (diagnosis, surgery, pathology, oncology, treatments, etc), keep track of the biobanked samples (e.g. blood and tissue), vital status, etc. To keep track of and couple this vast amount of data was a real challenge until 2018 when U-CAN decided to build a comprehensive data tracking system, named “Octopus”, capable of collecting and integrating data from various sources. Octopus is a web-based IT-solution that is centred on the Swedish personal-number system, which provides a common denominator for integrating data between systems. A connection with the Swedish census records provides information on birth-date, gender, county of residence and vital status. Connections with Uppsala Biobank’s LIMS-system provides real-time updates on all liquid biopsies (type of sample, status, number of remaining vials, etc). Clinical data is manually recorded by hospital-staff based on patient records, including notes on the reason why each new sample was taken. Octopus thus enables effective searches for patients, samples and available sample types to be included in various cancer studies, as well as serving as a depository for easy-access clinical data for research purposes. Moreover, Octopus is a pivotal and user-friendly hub for managing the U-CAN staff’s daily work-flow, for tracking patients between clinics, ordering new samples and entering new data. By creating Octopus, UCAN’s data management went from being fragmented and laborious to centralized and easy, while also providing an effective work-management tool for the whole project.

For over a decade the Swedish U-CAN project has routinely been biobanking liquid biopsies and tissue samples from cancer patients within different diagnosis types [1]. Consenting patients are followed longitudinally and new samples are collected throughout the course of their disease together with extensive clinical data. To date, >11.500 individuals have been included and around 500.000 samples been biobanked in Uppsala. In addition, patients answer surveys regarding lifestyle, health, comorbidities and heredity for cancer. The U-CAN resource is made available for cancer researchers worldwide. For each patient U-CAN needs to record consents, personal data, clinical data (diagnosis, surgery, pathology, oncology, treatments, etc), keep track of the biobanked samples (e.g. blood and tissue), vital status, etc. To keep track of and couple this vast amount of data was a real challenge until 2018 when U-CAN decided to build a comprehensive data tracking system, named “Octopus”, capable of collecting and integrating data from various sources. Octopus is a web-based IT-solution that is centred on the Swedish personal-number system, which provides a common denominator for integrating data between systems. A connection with the Swedish census records provides information on birth-date, gender, county of residence and vital status. Connections with Uppsala Biobank’s LIMS-system provides real-time updates on all liquid biopsies (type of sample, status, number of remaining vials, etc). Clinical data is manually recorded by hospital-staff based on patient records, including notes on the reason why each new sample was taken. Octopus thus enables effective searches for patients, samples and available sample types to be included in various cancer studies, as well as serving as a depository for easy-access clinical data for research purposes. Moreover, Octopus is a pivotal and user-friendly hub for managing the U-CAN staff’s daily work-flow, for tracking patients between clinics, ordering new samples and entering new data. By creating Octopus, UCAN’s data management went from being fragmented and laborious to centralized and easy, while also providing an effective work-management tool for the whole project.

Medical diagnostics has made magnificent improvements over the last few years and today clinical laboratory analyzers are technically highly advanced precision machines - but the quality of the blood samples and their inflow is largely unsecured and uncontrolled (“garbage in - garbage out”). Various scientific studies point to a so-called pre-analytical error between 1 and 12%. Any individual error can result in misdiagnosis, delayed/ wrong patient treatment or additional time- and cost consuming investigations. These errors are rarely the result of an analytical error in the laboratory, but mainly (up to 70%) originate from the prepreanalytical phase – the phase from the moment the test is ordered by a physician until the sample arrives in the laboratory after transportation [1] [2] [3]. S4DX developed a holistic solution for fully automated pre-preanalytical blood sample monitoring and quality assurance. The system consists of a small stationary sample registration device at the collection site for immediate sample registration after blood draw, a “SmartTube” for integrated sample monitoring during transportation and a cloud service for data processing and integration. Quantitatively and qualitative sample workflows are accessible in real-time and can be integrate into laboratory information systems (LIS) or laboratory analyzer middleware. As a result, the seamless and digital sample workflow audit trail allows laboratories to deal with regulatory burden, optimize the pre-analytical and analytical sample workflow processes, especially sample entry, as well as assure medical quality.

Medical diagnostics has made magnificent improvements over the last few years and today clinical laboratory analyzers are technically highly advanced precision machines - but the quality of the blood samples and their inflow is largely unsecured and uncontrolled (“garbage in - garbage out”). Various scientific studies point to a so-called pre-analytical error between 1 and 12%. Any individual error can result in misdiagnosis, delayed/ wrong patient treatment or additional time- and cost consuming investigations. These errors are rarely the result of an analytical error in the laboratory, but mainly (up to 70%) originate from the prepreanalytical phase – the phase from the moment the test is ordered by a physician until the sample arrives in the laboratory after transportation [1] [2] [3]. S4DX developed a holistic solution for fully automated pre-preanalytical blood sample monitoring and quality assurance. The system consists of a small stationary sample registration device at the collection site for immediate sample registration after blood draw, a “SmartTube” for integrated sample monitoring during transportation and a cloud service for data processing and integration. Quantitatively and qualitative sample workflows are accessible in real-time and can be integrate into laboratory information systems (LIS) or laboratory analyzer middleware. As a result, the seamless and digital sample workflow audit trail allows laboratories to deal with regulatory burden, optimize the pre-analytical and analytical sample workflow processes, especially sample entry, as well as assure medical quality.

Medical diagnostics has made magnificent improvements over the last few years and today clinical laboratory analyzers are technically highly advanced precision machines - but the quality of the blood samples and their inflow is largely unsecured and uncontrolled (“garbage in - garbage out”). Various scientific studies point to a so-called pre-analytical error between 1 and 12%. Any individual error can result in misdiagnosis, delayed/ wrong patient treatment or additional time- and cost consuming investigations. These errors are rarely the result of an analytical error in the laboratory, but mainly (up to 70%) originate from the prepreanalytical phase – the phase from the moment the test is ordered by a physician until the sample arrives in the laboratory after transportation [1] [2] [3]. S4DX developed a holistic solution for fully automated pre-preanalytical blood sample monitoring and quality assurance. The system consists of a small stationary sample registration device at the collection site for immediate sample registration after blood draw, a “SmartTube” for integrated sample monitoring during transportation and a cloud service for data processing and integration. Quantitatively and qualitative sample workflows are accessible in real-time and can be integrate into laboratory information systems (LIS) or laboratory analyzer middleware. As a result, the seamless and digital sample workflow audit trail allows laboratories to deal with regulatory burden, optimize the pre-analytical and analytical sample workflow processes, especially sample entry, as well as assure medical quality.