Clinical and medical research are founded upon the collection and analysis of confidential personal information.  Individuals will only share their sensitive information where there is a culture of trust and where stakeholders implement safe data handling practices.  Clinical Research of West Florida, Inc. (“CRWF”) recognizes that when we handle sensitive information about any individual, we must do so responsibly, with due care to individual privacy, and comply with the laws regarding data privacy and confidentiality.

This privacy policy describes the main types of personal information we process within our organization, how that information is used and disclosed, and our commitments to the individuals whose information we handle.  The Policy explains in general terms how we seek to comply with data privacy laws and regulations, including but not limited to the US Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), state security breach laws in the United States, data protection legislation adopted by increasing numbers of other jurisdictions globally, and the privacy and confidentiality requirements of ICH Good Clinical Practice (“GCP”).

CRWF has enacted internal policies, procedures and training programs designed to support compliance with these laws and this policy.  Our policies, procedures and training programs are reviewed on a regular basis.

What Types of Personal Information Does CRWF Handle and for What Purposes?

Clinical and Medical Information   

As a clinical research organization, CRWF conducts clinical trials for pharmaceutical companies. As such, we collect, host and analyze significant quantities of health data and bio-medical samples relating to study subjects. CRWF considers itself as co-controller with the sponsor/client in determining how and why clinical and medical data are processed in its capacity as a clinical research organization.

To enhance privacy, consistent with GCP, subjects’ names and other direct identifiers are not attached to records or samples utilized by CRWF’s clients for research purposes.

Clinical Trial Recruitment Information

We also collect and maintain personal contact information, details regarding health and medical conditions, and areas of interest in medical research from individuals who have expressed to us an interest in taking part in clinical trials, so that we are able to match them with a suitable clinical trial as they may arise. We use this information to recruit individuals for clinical trials and to run general statistical analysis in support of patient recruitment.

Health Screening Information

On some occasions, CRWF provides health services to local communities in the form of health screening activities for certain pathologies/diseases. During this activity, we collect names, contact information, and medical information of participants.  Once the test is performed, with the consent of the participant, we’ll add their information to our database so that they can be contacted by us for future testing or clinical trial opportunities, in line with their specific medical condition. Should they choose not to provide such consent, CRWF will only share results of the testing with the participant’s physician.

Industry Professional Information

In the course of conducting our business, CRWF will interact with employees, consultants, contractors and other third parties employed or engaged by our clients involved in clinical and medical research.  CRWF will record and use 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 CRWF’s services to our clients.

Employee and Human Resource Data

CRWF collects personal information from applicants seeking employment with the company, including private contact details, professional qualifications and previous employment history to inform employment decisions.  CRWF conducts various background checks on applicants, including where law allows on criminal history and professional disbarment.  Once employed, CRWF collects information on staff for human resource, performance, payroll and tax purposes.  CRWF will collect and record employee level information in various company systems, consistent with standard business operations.  CRWF processes similar information relating to consultants, contractors and other third parties engaged by the company to provide products or services to it.

Web Visitors

CRWF collects named information about visitors to company websites where this is voluntarily provided to meet a request from those individuals, for example where a client contact requests information on a company service, a health professional is interested in participating in a clinical trial or where someone wants to apply for a vacant position with the company.  Through the use of cookie-based technologies, CRWF may collect various data linked to virtual identities allocated to visitors when they access our websites.  This data is used for various purposes, including site analytics and first party marketing (see Online Issues below).  In certain cases, these virtual identities are linked to the real-world identities of visitors when they provide their named information as described above.  This allows CRWF to tailor marketing messages to those individuals, inclusive of information that is likely to be of interest to them.

Internal and External Disclosures of Personal Information

Personal information will be shared within CRWF and its affiliated companies and with third parties, including our agents and service providers, on a “need to know” basis to meet stated legitimate business purposes.  Access to databases and folders containing personal information is restricted to appropriate staff.  CRWF does not trade or sell personal information.

Under some circumstances, CRWF may be required by law enforcement or judicial authorities to disclose certain personal information as part of investigations or for litigation purposes.   CRWF may disclose personal information to a buyer or other successor in the event of a merger, divestiture, restructuring, reorganization, dissolution or other sale or transfer of CRWF or some or all its assets.

Companies working as vendors of CRWF are required to sign “processor” and/or confidentiality agreements whereby they will commit to only process personal information consistent with contracted purposes and apply appropriate organizational and technical security safeguards.

Notice and Consent

At the point of data collection, CRWF will provide notice to individuals in a clear and conspicuous language about how their information will be used, disclosed and transferred; what choices they have in relation to how their data are handled; what informational rights they have under data privacy law or under this Policy; and who to contact with any questions or complaints.  These privacy notices are tailored to specific situations of data collection.  In providing such notice, CRWF meets its obligations to be transparent and fair with individuals as is required by many data privacy laws.  Dependent on the medium, notice may be given in person, by email, post, telephone, or by posting on our website.

In many situations, including where mandated by data privacy law, and also where it is a matter of good practice, CRWF will seek consent of individuals to collect, use and disclose their data consistent with the relevant privacy notice.  However, in certain cases where law allows, particularly where gaining consent will involve a disproportionate effort, where intended processing of the data is in CRWFs or our clients’ legitimate interests and the privacy risks are low, CRWF will proceed to process personal information absent of consent.  Also, CRWF will use and disclose personal information without consent where required by law and judicial order.  Consistent with GCP, laws on confidentiality and data privacy regulations, CRWF will collect necessary informed consents of study subjects on behalf of its clients.

Data Quality and Record Retention

Data quality and accuracy are fundamentally important principles to CRWF  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, CRWF employs a professional quality assurance department.  In general, our privacy notices provide individuals easy means of validating, correcting errors and updating information.  CRWF retains personal information in accordance with contractual, legal and regulatory requirements.

Informational Rights

In jurisdictions with data privacy laws, and where contractual commitments require, CRWF ensures that individuals can exercise all relevant informational rights with respect to their personal information processed by the company, including but not limited to the right of access and correction, to withdraw consent at any time, object to data processing, request data deletion, restrict aspects of data processing, prevent direct marketing and request transmission of personal data in a common digital format (e.g. pdf) to the themselves or another organization.

In all other respects, where no overriding interest prevails, CRWF will endeavor to allow the following informational rights under this Policy as a matter of good practice:

• to allow access to copies of personal information within a reasonable timeframe;
• to correct personal information where inaccurate; and
• to withdraw a previously provided consent to processing of personal information.

Subjects enrolled in clinical studies run by CRWF must contact the investigator at their CRWF site, who will be able to make the necessary link to subject identity.

Online Issues

CRWF Web pages may contain links to websites outside of the company.  Linked websites are not under the control of or endorsed by CRWF  This Policy does not apply to linked websites outside the CRWF organization.  It is recommended that visitors review the privacy policy of each individually linked website.

Our web pages also use cookies.  A cookie is a data file that is placed by a website operator on the hard drive of a visitor to their site. CRWF and third parties with whom we work may place cookies with the following functions on the computers of visitors to CRWF websites:  to allow the site to deliver the service requested by the visitor; to remember repeat visitors; to improve the user experience of the site; to allow the company to perform site analytics; and to serve and help tailor our marketing messages on our websites and elsewhere on the internet  based on the visitor’s previous browsing activity.

Your online relationship with CRWF may be managed by using settings available on most internet browsers. At this time, we do not respond to “do not track” signals, however most browsers will allow a visitor to choose which cookies can be placed on his/her computer and to delete or disable cookies.  Please note that disabling cookies may prevent a visitor from using certain features on CRWF websites.

Children’s Online Privacy Protection

CRWF does not collect information through our websites from individuals who are known to be under the age of 13, and no part of our online presence is directed to anyone less than 13 years.

Inquiries, Complaints and Requests to Exercise Rights

Communications, queries, requests to exercise informational rights (e.g., access to data) or complaints can be emailed to research@crwf.com.

Legal Status of Policy and Policy Changes

This Policy is not a contract, and it does not create any legal rights or obligations.  CRWF reserves the right to modify or amend this policy.  For instance, the policy may need to change as new legislation is introduced or as it is amended.  The updated policy will be posted on www.crwf.com.