1. Purpose
The purpose of this document is to describe SIRO’s Privacy Policy.
2. Responsibility
This guideline is applicable to all departments/ functions across SIRO India, Europe and USA operations.
3. Privacy Policy
SIRO Clinpharm Pvt. Ltd., its subsidiaries and affiliates in USA and Europe (hereafter collectively referred to as “SIRO”) receive from various countries
different types of data including personal information about clinical research subjects, patients, investigators and staff, service providers and business
partners, health care professionals, employees, potential employees, employees of a third party for temporary employment or consulting agencies, sponsors of
clinical research, suppliers, and industry experts all in support of SIRO’s clinical research operations.
SIRO maintains a strong commitment to protect confidential and personal information (PI). Our sponsors, investigators, study subjects, employees and all
those who do business with us expect us to maintain in trust and confidence and not distribute, disseminate, transfer, disclose or otherwise make available
to any third party, or use for any unauthorized purpose their confidential or personal information. Accordingly, SIRO adheres with all the obligations of
privacy requirements and complies with applicable laws and regulations with respect to the processing of trial data including specific data protection and
data security laws defined by our sponsors in our contracts with them. Protecting confidential information is not only a business requirement for SIRO but
also an ethical and legal requirement.
The following privacy principles apply to the collection, use and disclosure of PI by us in conducting our clinical research activities.
3.1 Definition, Source and Uses of Personal Information
Personal Information means any information pertaining to an individual that can be used to easily identify the individual or with reasonable efforts
identify that individual. PI may include information relating to individually identifiable health related details, details included in a curriculum vitae,
distinct identifiers like the names, address, age, telephone, fax, email ids, bank account details, photo images, IP addresses etc. or details contained in
correspondences received from individuals or a corporate to requests for proposals received.
We receive PI from clinical research subjects, employees, potential employees, employees of third party vendors, consultants and other industry experts.
This list is broadly indicative and cannot be classified as exhaustive.
For the purposes of clinical research, SIRO can use and disclose PI with individual authorization and under limited circumstances without individual
authorization.
3.2 Notice
We will inform all individuals who share their PI with us about the purposes for which we collect and use this Information the third parties with whom
we may share this Information, and the manner by which individuals may limit the use and sharing of this Information. This notice will be provided when
individuals are first asked to provide PI or as soon as operationally practicable thereafter.
3.3 Onward Transfer
PI collected from individuals during the course of our business is processed by us for its accuracy and completeness. It is stored and maintained up to date
based on our SOP requirements. The PI may be transferred by us:
- to our current or potential clients/ vendors/ business associates or
- to regulatory authorities in the respective countries where SIRO has its offices or to the regulatory authorities of other countries or
- to our employees or consultants
Such current and potential clients/ vendors/ business associates/ employees/ consultants of SIRO may also disclose or transfer the PI shared with them to
their affiliates or to regulatory authorities in other countries to facilitate the determination of SIRO or SIRO employees’ involvement in projects
involving mutual collaboration and/or to comply with regulatory requirements.
We will only transfer PI to clinical trial sponsors and to other third parties who have been identified in the notice provided to the individual who is the
subject of the data and who has consented for such transfer.
We will transfer PI to only those sponsors and other third parties where these parties have signed confidentiality agreements and given assurances that they
will provide at least the same level of privacy protection as is required by our privacy principles. Where we get information that any party is using or
sharing PI in a way that is contrary to these principles, we will take reasonable steps to prevent or stop such processing.
3.4 Access and Choice
We offer individuals the right to inspect and obtain a copy of their PI. They can request amendments to their PI in case they find it incorrect or
incomplete.
Individuals are also free to revoke an Authorization. But, in case the individual is a participant of a clinical study we may continue to use the PI in
certain cases, even after such revocation. We may continue to use the PI to account for the individual's withdrawal from a study in order to maintain the
integrity of that study.
3.5 Information Security
We will take reasonable precautions to protect the PI from unauthorized access, use, disclosure, disruption, modification, destruction or loss.
3.6 Enforcement
We will obtain PI only by lawful and just means and comply with relevant privacy and data protection laws as requested by our sponsors.
We are committed to address complaints or disputes regarding PI promptly and courteously. Any person, including employees or former employees who has
questions about the way in which we use or have used their PI may email:
privacy@siroclinpharm.com
3.7 Limitation on Scope of Principles
We may be obliged to disclose PI to meet a legal, governmental, national security or public interest obligations.
3.8 Changes to this Policy
This Policy may be amended from time to time, consistent with the requirements that SIRO may have to adhere to. We will notify employees by sending an
internal communication and all other individuals by placing a notice on the company web site.
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