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This Policy also sets forth how ERT will handle client clinical data transferred from both foreign (including data received from the European Economic Area – EEA) and domestic investigator sites which are collected or received in managing and in conducting clinical research activities. ERT receives Sponsor defined encoded, pseudonymised and anonymised study subject demographic information during the contracted management of clinical trials.
ERT complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries and Switzerland. ERT has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. To learn more about the Safe Harbor program, and to view ERT’s certification, please visit http://www.export.gov/safeharbor/
The following terms are used throughout this document and are defined here for clarification.
“Agent” means a third party that processes personal data solely on behalf of and under the instructions of the study Sponsor. Additionally, “Agent” means any ERT Corporate representative that collects/processes personal data for the purposes of employee management including third party processers.
“Personal/Clinical Information or Data” means any information or set of information that identifies or can reasonably be used to identify an individual. Personal/Clinical information includes information that is encoded or anonymized, or publicly available information that has not been combined with non-public personal information.
ERT collects employee Personal Information or Data for the following reasons which include but are not limited to: employee management and administration generally (including both during and after employment), employment verification, administering employee benefits, administering personal short or long term compensation programs or benefits, evaluating performances, managing corporate programs, conducting disciplinary proceedings, addressing labor relations issues, processing health insurance claims. ERT also contracts with third party providers to render related services, including payroll processors and support services.
Sensitive Personal Data
"Sensitive personal data" means personal information that reveals race, ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, or that concerns health or sex life. Information will be treated as sensitive personal data where it is received from a third party that treats and identifies it as sensitive.
ERT collects only directly relevant information considered to be “sensitive personal data” for ERT employees both foreign and domestic (for example, race statistics for US Affirmative Action Plans).
The following privacy principles apply to the collection and use of personal/clinical data by ERT for employee management and conducting clinical research activities.
ERT will, as required by law, notify individuals about the purposes for which it collects and uses Personal Information, how to contact ERT, the types of third parties with which it shares that information, and the choice and means ERT offers individuals for limiting the use and disclosure of Personal Information about them. Through ERT’s controlled document management system, ERT will issue, as a training requirement, notification regarding ERT’s intended use of Personal Information. This information will be provided as soon as practicable and, in any event, before ERT uses the information for a purpose other than that for which it was originally obtained.
ERT will not issue notice when contracted to acquire, process and report data received during the active status of Sponsor defined clinical trials. ERT does not have direct interaction with any study subject or their medical history. ERT does not have access to source records and is not responsible for study subject verification. ERT does not hold contracts with Investigators selected by the Sponsor nor is ERT involved in Informed Consent or IRB activities all of which are the responsibility of the study Sponsor.
ERT will, as required by law, offer individuals the opportunity to choose whether Personal Information about them is Processed for purposes other than those for which the information was originally obtained or was subsequently authorized by the individual (“opt-out”). Unless required by law, ERT will not Process Sensitive Personal Information about individuals for purposes other than those for which the information was originally obtained or subsequently authorized by the individual unless the individual affirmatively and explicitly consents to the Processing (“opt-in”).
ERT will not offer choice when contracted to acquire, process and report data received during the active status of Sponsor defined clinical trials. ERT does not have direct interaction with any study subject or their medical history. ERT does not have access to source records and is not responsible for study subject verification. ERT does not hold contracts with Investigators selected by the Sponsor to recruit study subjects nor is ERT involved in Informed Consent or IRB activities all of which are the responsibility of the study Sponsor.
ERT will provide individuals with reasonable access to their own Personal Information, upon request, subject to permitted exemptions. ERT will also take reasonable steps to allow individuals to review Personal Information about them for the purposes of correcting such information.
ERT will not offer access to clinical trial participants enrolled in Sponsor defined clinical trials as ERT does not have direct interaction with any study subject or their medical history. ERT does not have access to source records and is not responsible for study subject verification. ERT does not hold contracts with Investigators selected by the Sponsor to recruit study subjects nor is ERT involved in Informed
Consent or IRB activities all of which are the responsibility of the study Sponsor. Upon completion of the contracted study ERT delivers as contractually required all final clinical data received and processed to the study Sponsor.
As a standard, ERT does not receive or collect clinical or sensitive personal identifying information such as study subject name or medical record number. ERT only receives blinded, encoded, pseudonymised and anonymised study subject study subject identifiers (demography) to confirm uniqueness as defined by the study Sponsor (e.g. Date of Birth, gender, etc.). ERT does not have direct interaction with any study subject or their medical history. Additionally, ERT does not have access to source records and is not responsible for study subject verification. ERT only collects employee personal information within the EU for the purposes of employee management.
ERT will only transfer Personal Information about individuals to an agent where the agent has provided adequate assurances to ERT that it will protect the information consistently with this Policy. Where ERT has knowledge that an agent is Processing Personal Information in a manner contrary to this Policy, ERT will take reasonable steps to prevent or stop the Processing.
ERT will only transfer clinical/personal data collected to a Sponsor or a Sponsor approved third party “Agent” as required by authorized business contracts. ERT will only subcontract to firms which demonstrate adequate privacy protection standards. The Sponsor will be notified of the use of any subcontractors utilized which requires the transfer of clinical/personal information.
ERT will only transfer personal data to a non-agent third party in a manner consistent with the principles described within the “Notice” and “Choice” sections of this Policy.
ERT will only use and share clinical/personal data in a way that is consistent with the purposes for which the data were collected or subsequently authorized. ERT seeks to collect Personal Information that is adequate, relevant and not excessive for the purposes for which it is to be processed. ERT employees have a responsibility to assist ERT in maintaining accurate, complete and current Personal Information collected and Processed in the course of conducting human resource and related activities. ERT will only use and share clinical/personal data in a way that is consistent with the purposes for which the data were collected or subsequently authorized by the Sponsor/Employee. To the extent necessary for those purposes, ERT will take reasonable steps to ensure that the data are accurate, complete, and current.
ERT will take reasonable precautions to protect personal data in its possession from loss, misuse and unauthorized access, disclosure, alteration and destruction.
ERT’s cardiac safety, respiratory services and ePRO systems employ role based functionality that reside behind ERT’s firewall. Individual user roles are defined by management personnel and require the use of an active User ID and complex password to gain access to the system. Also, ERT’s clinical systems incorporate a defined workflow for the processing of clinical data received during the active status of any contracted study. Additional security measures include: daily backups which are retained on-site in a fireproof safe, weekly backups that are sent off-site for 5 weeks thus allowing for the monthly back up to be completed for indefinite off-site storage. ERT’s systems physically reside at an off-site data center with all system maintenance managed by ERT personnel. Data replication to the backup instance occurs during regularly scheduled intervals. Routine audits of these processes ensure adherence to ERT Standard Operating Procedures.
ERT has established internal mechanisms to verify ongoing adherence to this Policy. ERT encourages individuals covered by this Policy to raise any concerns they have regarding the Processing of Personal Information
It is the policy of ERT to neither tolerate or ignore possible misuse of clinical/personal information received. All employees are responsible for reporting any suspected cases of misuse or disclosure of clinical/personal data to ERT Quality Management or an ERT Corporate Officer. ERT’s Quality Assurance department is responsible for the oversight of the formal investigation to review initial evidence and/or data and then reach and document that there is/is not a need for further action. ERT will take all necessary steps to ensure protection of our employees, study subject safety and to protect the integrity of the data being collected. The study sponsor and/or the third party contracted for the management the sponsor’s clinical trial(s) will be informed.
In cases of substantiated evidence of suspected personal information misuse or disclosure the study sponsor and/or the third party contracted for the management the sponsor’s clinical trial(s) will need to be informed, in writing upon confirming conclusions. Misuse or disclosure of personal/clinical information found to be committed by ERT personnel is considered grounds for disciplinary action.
ERT has put in place mechanisms to verify our ongoing adherence to these privacy principles. ERT encourages Sponsors with whom we are currently contracted or employees to raise any concerns that they have about the way that we process their personal/clinical data by contacting us at the address below.
1818 Market Street, Suite 1000
Philadelphia, PA 19103
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