Privacy Policy

 

 Introduction

Depending on the CRO services HabcareCRO is providing to a Sponsor we process personal data relating to study participants on behalf of our Sponsors and in accordance with contracts with and instructions from the Sponsor.

Clinical and medical research are founded upon the collection and analysis of the most confidential information about people. Individuals will only share their sensitive information where there is a culture of trust and where stakeholders implement safe data handling practices . This Global Privacy Policy  describes the main types of personal information we process within our global organization, how that information is used and disclosed, and our commitments to the individuals whose information we handle. This policy applies to all information either in electronic or paper format received by HabcareCRO.

Applicability

This Policy is applicable to the Company and/or Covered Parties as defined in the above.

 Purpose

The purpose of this Policy is to establish the proper rules to identify privacy policy of HabcareCRO.

General Principle

We collect, host and analyze significant quantities of health data and bio-medical samples relating to study subjects on behalf of our clients. To enhance privacy, consistent with GCP, subjects’ names and other direct identifiers are not attached to records or samples collected by HabcareCRO for research purposes. Instead, subjects are only identified by a code. Only study doctors and authorized personnel, including HabcareCRO monitors  may access named subject records at source. Depending on the CRO services HabcareCRO is providing to a Sponsor we process personal data relating to study participants on behalf of our Sponsors and in accordance with contracts with and instructions from the Sponsor.

How We Use the Information

In general, with exceptions and other lawful bases that may be relevant for any specific service notice, HabcareCRO processes personal data for its legitimate interests consistent with applicable law, local regulations and ICH GCP.

For example, this may include things like:

 Account set up and administration

 Delivering information about services, trainings and events

 Providing services

 Legal obligations (e.g. prevention of fraud)

 Meeting internal audit requirements

 Conduct personnel recruitment

HabcareCRO may offer individuals the opportunity to choose whether their personal information is (a) to be disclosed to a third party, or (b) to be used for a purpose materially different from the purpose for which it was originally collected or subsequently authorized by the individual.

HabcareCRO will not disclose sensitive personal data, defined as:

Demographic data (e.g. sex, race, colour, ethnic or national origin, religion, philosophical or political beliefs, trade union membership and criminal proceedings); and Medical data (e.g. pre-placement medicals, and other medical documents produced for the purposes of employment, such as, drug screen results)

When do we share personal data?

HabcareCRO may be obliged to disclose certain personal information to third parties such as Government Authorities or law enforcement agencies or to provide information in respect of a matter related to public safety. It may also be necessary to disclose personal information so as to protect the legal interests and other rights of HabcareCRO, subject to local legal requirements.

HabcareCRO may disclose certain personal information to a supplier or contractor organization supplying services which require the use and/or creation of personal information. In these cases, HabcareCRO ensures adequate security is observed by third parties and affiliates processing personal information on behalf of HabcareCRO, subject to local legal requirements.

In the course of conducting our business, HabcareCRO interacts with employees, consultants, contractors and other third parties employed or engaged by our clients involved in clinical and medical research. HabcareCRO records and uses the names, contact details and other professional information on these individuals for legitimate business-related purposes, including project and financial administration. We may use the information we obtain, including email addresses, to provide relevant information on HabcareCRO’s services to our clients.

Data quality and accuracy are fundamentally important principles to HabcareCRO. Crucial to the integrity of clinical research is the accuracy of data relating to study subjects, particularly where attached to bio-medical samples. Consistent with regulatory requirements, HabcareCRO employs a professional quality assurance department. In general, our privacy notices provide individuals easy means of validating, correcting errors and updating information. HabcareCRO retains personal information in accordance with contractual, legal and regulatory requirements.

Responsibilities

It is everyone’s responsibility and obligation within the Company and/or Covered Parties, to know, comply, request compliance with, and report any violations of: i) our Code of Conduct; ii) the ABAC Policy, iii) the applicable international and local laws and regulations; and iii) other applicable policies and procedures. In addition, all people in Company management positions are expected to ensure that their employees are fully aware and understand the provisions of this policy.

Disciplinary Measures

Non-compliance with the laws and/or our policies and procedures may result in disciplinary

Questions and Comments

We cannot anticipate every possible situation that might arise in our daily activities, so if you have any questions or comments in regards to this policy, please communicate with the Quality Assurance Department or emailed to [email protected].

Reporting Procedures

If you have any actual or suspected violations that you want to report, we encourage you to discuss them with your Line Manager or the Quality Assurance Department or alternatively the Legal Department. The Company does not allow retaliations against any Covered Parties who in good faith reports any suspected unethical or illegal misconduct.