PURPOSE & SCOPE:
The confidentiality of records that could identify subjects (Trial Patients) should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements.
All individuals within Tempcon play a role in ensuring overall privacy risk management and data protection compliance.
All individuals within Tempcon play a role in ensuring overall privacy risk management and data protection compliance.
WHAT IS PERSONAL DATA?
Patients’ personal data collected in clinical trials may include following but not limited to medical history, phenotype (set of observable characteristics such as anatomy, morphology), genotype (gene composition), and so on.
Name, age, gender, address
Disease/health related information
Contact details
Genetic or biometric data
Pictures
Financial data
Passwords
IP addresses
Online search history
Political opinions
WHAT TEMPCON STAFF CAN DO TO PROTECT PERSONAL DATA?
If Tempcon staff is required access to patient personal data for the purpose of transportation of shipments, the CDA must cover this requirement and following points as applicable must be agreed between all the parties involved.
- Our clients should be able to know what information has been collected about trial subjects /patients by Tempcon, the purpose of its use, who can access and use it, and where it resides. They should also be informed about how they may obtain access to information collected and how they may control who has access to it.
- Personal data should not be disclosed, made available, or otherwise used for purposes other than those specified.
- All personal data collected should be relevant to the purposes for which they are to be used and should be accurate, complete, and up to date.
- Reasonable safeguards should protect personal data against such risks as loss or unauthorized access, use, destruction, modification, or disclosure at your branch.
- Staff in control of personal health information must be held accountable for implementing these principles. they should know who is storing what information on them, and how that information is being used. They should also be able to review the way their information is being used or stored and duration of the storage.
WHAT TEMPCON STAFF CAN DO IN CASE OF PERSONAL DATA LEAK?
- Inform QA or Management immediately upon identifying any information accidentally or knowingly /unknowingly, leaked or spread to unnecessary person/s or institution/s.
- It is not any staff responsibility to deal with data leak or measures to take without notifying to the QA and /or Management. In case of requirement to take the immediate action of recall or delete the information being shared/leaked, it can be done and require immediate notification to the QA/Management.
- QA & Management is responsible to provide remedies to address security breaches or privacy violations.
Please contact us for more detailed policy updates to know more.
Quality: qa@tempconexpress.in
Compliance: compliance@tempconexpress.in
Quality: qa@tempconexpress.in
Compliance: compliance@tempconexpress.in
