Clinitrials recognizes the need for compliance with its obligations under the Privacy Act 1988 and the Australian Privacy Principles prescribed under that Act (“the Privacy Act”).
Clinitrials provides support services for the conduct of clinical trials. We collaborate with clinicians, research organisations and research sites to facilitate the successful delivery of clinical trials/ research. The purpose of this document is to provide you with information about how Clinitrials collects, holds, uses and discloses personal information to carry out these functions.
When individuals register to participate in a clinical trial this information is held in a database by Clinitrials . We ask your permission to include your details. The database allows Clinitrials to contact those registered about potential clinical trials or medical research projects to which they may be suited to.
Personal information means information or an opinion about an identified individual, or an individual who is reasonably identifiable:
- whether the information or opinion is true or not; and
- whether the information or opinion is recorded in a material form or not.
Sensitive information is a type of personal information and includes information about an individual's:
- health (including predictive genetic information)
- racial or ethnic origin
- political opinions
- membership of a political association, professional or trade association or trade union
- religious beliefs or affiliations
- philosophical beliefs
- sexual orientation or practices
- criminal record
- biometric information that is to be used for certain purposes
- biometric templates.
Health information means:
- information or an opinion about:
- the health, including an illness, disability or injury, (at any time) of an individual; or
- an individual’s expressed wishes about the future provision of health services to the individual; or
- a health service provided, or to be provided, to an individual;
that is also personal information;
- other personal information collected to provide, or in providing, a health service to an individual;
- other personal information collected in connection with the donation, or intended donation, by an individual of his or her body parts, organs or body substances;
- genetic information about an individual in a form that is, or could be, predictive of the health of the individual or a genetic relative of the individual.
De identified information means personal information that is no longer about an identifiable individual or an individual who is reasonably identifiable.
Personal information that has been de-identified is no longer considered to be personal information. Similarly, personal information that is in the public domain is no longer considered to be personal information.
Collection of Personal Information
As a participant or prospective participant in a clinical trial, the collection of personal and sensitive information is a necessary part of ensuring that:
- we are able to provide you with information about clinical trials;
- only suitable participants are included in clinical trials;
- we are able to communicate with you in a timely manner
- we comply with our legal obligations
The content of any electronic forms you submit by means of this website requesting us to register your interest as
- a participant in clinical trials
- health professional requesting information about clinical trials
- health professionals referring an individual participant for a clinical trial ( who has consented to the referral )
whether general or in relation to a specific trial appearing on the Clinitrials website may include but is not limited to:
- sex / gender
- date of birth
- contact details - telephone numbers, email address
- health and medical interest you disclose
Clinitrials may also collect personal information (including sensitive information) about you from publicly available sources.
Use and Disclosure of your Personal Information
Use of Your Personal Information
In addition to registering an individual’s request to be considered for participation in a clinical trial or being referred for a clinical trial Clinitrials may use or disclose personal information for our business and as permitted by law. Such purposes include the following:
- to establish and maintain a database of potential participants for clinical trials;
- to establish and maintain a database listing of health professionals referring trial participants
- for the specific purpose for which we have collected the information;
- managing the services we provide;
- enabling collaborators with Clinitrials to promote their clinical trials to those registered by means of the Clinitrials website;
- purposes related to our research, planning, product and service development, security and testing;
- purposes connected with the operation, administration, development or enhancement of this website;
- where we suspect that fraud or unlawful activity has been, is being or may be engaged in;
- meeting any legal and regulatory requirements we are subject to, or may be imposed upon Clinitrials;
Disclosure of Your Personal Information
We will not disclose your personal information to unauthorised personnel at any time. Where the Privacy Act permits it, Clinitrials may disclose your personal information to third parties. Third parties that we may disclose your personal information to include:
- entities providing services to Clinitrials including legal services, financial services, data providers, storage services and mailing houses;
- government regulatory bodies in Australia and overseas;
- entities who may wish to be involved in our business, or acquire an interest in our business;
- third parties you authorise to act on your behalf or that are otherwise connected with you (such as your legal representative or other authorised agent or attorney); and
- law enforcement agencies.
Access to Clinitrials records and disclosure of your personal information is limited to those who have an operational need or who have legislative authority. These include but are not limited to:
- Clinitrials personnel;
- auditors appointed by sponsors, certifying authorities or ethics committees;
- the Commonwealth Ombudsman;
- the Office of the Australian Information Commissioner;
- Administering Institutions;
- the Australian Taxation Office; and
- the Australian Federal Police.
Clinitrials will not be taken to have breached its obligations under this policy or the Privacy Act where:
- a person has consented to the use or disclosure of their personal information;
- a purpose for which the personal information is to be used is directly related to the purpose for which it was collected;
- a person would reasonably expect, or has been told, that personal information may be published or passed to certain individuals, bodies or agencies (e.g. if requested by the Australian Taxation Office);
- the disclosure of personal information:
- is required or permitted by law; or
- will prevent or lessen a serious and imminent threat to somebody’s life or health,
- there is a reasonable belief that the disclosure of the personal information is for a purpose directly related to the enforcement or investigation of a possible breach of a Commonwealth, State or Territory law; or
- the personal information is in the public domain.
Email addresses provided by means of this site will only be used to respond to specific user registrations and will not be disclosed to any other party without your knowledge, consent, or direction unless required by law.
Access, Correction and Removal of your Personal Information
Access to your Personal Information
You have specific rights under Australian Law to request access to and correction of personal information that Clinitrials holds about you.
You can request access to the personal information that Clinitrials holds about you subject to certain exceptions under the Privacy Act. You are also entitled to specify how you wish to access your personal information, so long as this is reasonable and practicable.
Given that the information we will have is of a sensitive nature we will need to verify the identity of anyone requesting access to your personal information, so as to ensure that we do not provide that information to a person or people who do not have the right to access that information. In furtherance of this objective we ask that any requests for information be as specific as possible so that we can accommodate your request. We will usually provide you with access within thirty (30) days of a request but in some circumstances it may take longer.
Please note that under Australian law, Clinitrials is entitled to refuse you access to your information in the following circumstances:
- where access would be unlawful;
- denying access is required or authorised by or under an Australian law or a Court / Tribunal order; or
- access would prejudice enforcement activities or the taking of appropriate action in relation to unlawful activity or serious misconduct.
Correction or Removal of your Personal Information
Clinitrials takes every step that is reasonably practicable to ensure that the personal information we collect, use and disclose is accurate, complete and up to date. To facilitate this, please let us know if any of your details change or in the event you wish your personal information to be removed from our database as the Privacy Act gives you the right to request correction or removal of the personal information we hold or if that personal information is incorrect. In order to do so, please contact Clinitrials via our email at email@example.com.
Security and Storage of Personal Information
Clinitrials takes steps to protect the security of the personal information it holds. We may hold your information in paper or electronically.
- Paper records are stored in locked rooms with limited access
- Electronic database is stored on password protected servers
For further information on the way Clinitrials manages security risks in relation to personal information please contact us via email at firstname.lastname@example.org.