NSGO-CTU – The Clinical Trial Unit

Our Story

NSGO-CTU was founded in 2006.
We are a non-profit organization with the main objective to manage and support clinical research in gynaecologic cancer.

While the organization’s Danish name is, “Nordisk Selskab for Gynækologisk Onkologi’s Kliniske Forskningsfond,” it is commonly referred to as NSGO-CTU and is headquartered at Rigshospitalet in Copenhagen, Denmark.

As a recognized international group and collaborative partner, our daily focus is on developing, initiating, and conducting quality clinical trials within the field of gynaecological oncology to contribute to future advances for patients.

NSGO-CTU is overseen by a Medical Director who is accountable to the NSGO-CTU Foundation Committee, also known as the NSGO-CTU Foundation Board. The Medical Director is appointed for three-year terms and may be reappointed indefinitely in the best interest of the Foundation and NSGO-CTU.

Dr. Kristine Madsen (DK) is appointed Medical Director to manage the Clinical Trial Unit.

NSGO-CTU collectively consists of:

The Medical Director
The NSGO-CTU Foundation Committee
The staff of the NSGO-CTU Office
The NSGO-CTU Scientific Committee

The Mission

NSGO-CTU are strong collaborators among professionals in the field of gynaecological cancer. The Clinical Trial Unit conducts educational meetings for colleagues and industry partners.

We organize the Biannual NSGO-CTU Investigator Meeting in Copenhagen and provide updates on the latest developments in cancer research.

NSGO-CTU is affiliated with ENGOT and maintains partnerships with GOG to advance clinical research in the field of gynaecological oncology. In addition to conducting clinical trials in the Nordic countries, our society aims to provide education and training to future Principal Investigators (PIs) and sub-investigators.

Our activities also involve mentoring other groups & organizations and promoting collaboration and camaraderie among experts and organizations worldwide engaged in the field of gynaecological oncology.

The Purpose

Clinical trials are an integral component of medical research that assesses the safety, efficacy, and effectiveness of new drugs, medical devices, or treatment modalities. These trials typically involve a complex and multi-faceted process that involves many different stakeholders, including clinicians, researchers, patients, regulatory bodies, and funding agencies. Given the complexity of clinical trials, it is crucial to have effective project management in place to ensure that the research progresses in a timely and efficient manner and that all stakeholders are engaged and informed throughout the process.

As a project management team for clinical trials research, our primary responsibility is to oversee and coordinate all aspects of the research project from start to finish. We work closely with clinical trial investigators to design and develop the trial protocol, define inclusion and exclusion criteria, and identify the appropriate patient population for the study. We also collaborate with regulatory bodies to ensure that the study meets all ethical and regulatory requirements.

One of our critical roles is to oversee the recruitment of patients and ensure that the study is conducted in compliance with Good Clinical Practice (GCP) guidelines. We develop a detailed project plan that outlines the timelines, milestones, and deliverables for the study and ensure that the research team adheres to the plan. We monitor the progress of the study, identify any issues or concerns that arise, and take corrective action as needed to keep the project on track.

Another essential function of our project management team is to facilitate communication and collaboration among all stakeholders. We work closely with study sponsors and funding agencies to ensure that they are updated on the project’s progress and that the study remains aligned with their goals and objectives. We also communicate regularly with the clinical trial investigators and research team to ensure that they are aware of any updates or changes in the study design, protocol, or timelines.

Our responsibility is to ensure that the research project is conducted efficiently, ethically, and in compliance with regulatory guidelines & ensure effective communication and collaboration throughout the project.

NSGO-CTU Office

NSGO-CTU Leadership

Kristine Madsen

Medical Director

Alice Henius

Chief of Staff

NSGO-CTU Team

Adela Ioana Buda

Financial & Event Coordinator

Johanne Hestvang

Senior Project Manager
ENGOT & GCIG Rep.

Sanne Nygaard Lindberg

Senior Project Manager

Line Jensen

Senior Project Manager

Alex Birkbak Thomsen

Project Manager

Datamanagement & REDCap

Marie-Louise Brødsgaard Abrahamsen

Project Manager

Anne-Sofie Lindblad Nissen

Project Manager

Rebecca Drivsholm Sand

Project Manager

Christina Steen Vorbeck

Clinical Trial Manager

Julie Ardenkjær-Kastrup

Project Manager

Henriette Watson Hansen

Project Manager

Mia Sejer Donner

Contract Manager
(On Maternity leave)

Karen Stampe Petersson

Project Manager
(On Maternity leave)

NSGO-CTU Address:

Nordic Society of Gynaecological Oncology – Clinical Trial Unit
Department of Cancer Treatment, 9431
Rigshospitalet
Copenhagen University Hospital
Blegdamsvej 9
DK-2100 Copenhagen, Denmark

Call us:

Phone: +45 35 45 33 11

Phone hours:
Monday – Thursday: 09.00 – 15.00
Friday: 09.00 – 14.00

Get in touch:

NSGO-CTU Bylaws

The Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU) operates under a structured set of bylaws that govern its operations. By maintaining clear and up-to-date bylaws, NSGO-CTU strengthens its governance, supports collaborative decision-making, and reinforces its commitment to excellence in gynaecological oncology across the Nordic region.

You can find the newest version of the NSGO-CTU Bylaws through the button bellow:

Foundation Governance

Foundation Committee

The NSGO-CTU Foundation Committee (Board members) is named for a two-year period.

Scientific Committee

The Scientific Committee of NSGO-CTU (SC) consists of Investigator representatives from the top recruiting sites in the Nordic and Baltic countries, as well as the NSGO-CTU Foundation President and President elect. Prior NSGO presidents, and NSGO members are all invited to join the meetings.

The SC meets 8-10 times a year for Scientific Committee Meetings (SCM), where new trial proposals and trial updates are presented, reviewed, and discussed jointly. The NSGO-CTU SCM’s are arranged by the NSGO-CTU office and are led by NSGO-CTU Medical Director.

New trials within gynaeoncology are presented during the SCM, which incl. NSGO-CTU Sponsored trials, Pharma sponsored trials, and clinical trials sponsored by collaborating ENGOT groups. Following initial study presentation, the SC will evaluate and discuss the interest of NSGO-CTU to join new trials, incl. review any identified challenges regarding study design, competing trials, financial aspects, and feasibility aspects of NSGO-CTU sites for recruitment.

To be a Primary Investigator for NSGO-CTU trials, it is mandatory to be an active NSGO-member.

The SCM also include scientific presentations and updates from relevant annual conferences within gynaeoncology (e.g., ESMO, ESGO, ASCO), as well as broad discussions regarding e.g., international collaborations, translational research, and educational initiatives.

The members of the Scientific Committee are reviewed annually to accommodate for changes in recruitment status the prior year.

Translational Research Group

Mission Statement:

To move translational science toward greater health impact for gynecological cancers.

Objectives:

To promote and formalize translational research work within NSGO.

The main activities are:

To participate in writing of protocols for NSGO-CTU lead clinical trials to secure design, sample size and sample collection for proper translational research.
To establish standards operation procedures for:
- Sample collections and biobanking.
- Publication rules.
- Data ownership.
- External collaborations.

Members:

Privacy Policy for NSGO-CTU

NSGO-CTU treats personal information and complies with the laws and principles of good data
processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO-CTU is the data controller and you can contact the organization’s data protection officer:

Mansoor Raza Mirza

Nordic Society of Gynecologic Oncology – Clinical Trial Unit
Copenhagen University Hospital
Department of Oncology, 9431
Blegdamsvej 60
DK-2100 Copenhagen
Office phone: +45 35 45 33 78
fax: +45 3545 2898
nsgo-dpo.rigshospitalet@regionh.dk

We treat the following personal information about personnel participating in NSGO-CTU trials:
• General personal information: For example; contact information such as name, work
address, work phone number, date of birth, email address, country, work title, date of start
of participation and termination in a trial and, if applicable, CV, GCP certificates, records of
training and other qualification data.
• If applicable, financial disclosure forms and/or Bank account number for reimbursement
purposes.

We collect personal information from:
• We will ask you to provide us the information yourself, when you in decide to take part
in NSGO-CTU trials.
The organization’s legal basis to process personal information:
• That we as an organization have a (legitimate) interest in processing your information, for
example to secure your qualifications in handling the care of the participants in a trial.
• That it is necessary for us to fulfill an agreement with your employer
• You have agreed that we can process your information via signing the delegation log.
The purpose of processing personal information:
• The participation of an investigator or of other individuals in a clinical trial which is being
conducted according to the principals governing clinical research as set out in the
Declaration of Helsinki and with the acceptance of all involved Regulatory Health
Authorities and involved Ethical Committees, requires collection, recording, storage,
transfer and/or other use of personal data (personal data processing).
• Communicate regarding studies.
• To handle payments and reimbursements.
• To comply with legislation.
• To deliver services, in the form of the possibility to participate in the Annual Meeting,
Investigator Meeting.
• To be able to give you access to IT systems, databases, eCRFs etc. related to the functioning
of each individual trial.

Consent:
When you decide to take part in a NSGO-CTU trial NSGO-CTU either makes a contract with you or
your employer where terms and conditions are described, or if you put your name on the
Delegation Log of a trial, you agree to the information described in this Privacy Policy.
However, it may happen that we judge it necessary to obtain your written consent for other
purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it
at any time by notifying us.
Be aware that there are legal bases for certain forms of processing of your data for the abovementioned purposes and that your consent is the only legal basis for other forms of processing.

Dispatch of your personal information:
Depending on your role in a trial, your personal information might be shared with personnel at
other sites, monitors, group staff in other countries, NSGO-CTU office staff, members of NSGO,
CRO staff, Ethics Committees and Competent Authorities, both in Europe, but also in countries
outside the European Economic Area (for example the US). If your data (personal information) has
been transferred, they will be subject to the data protection legislation of the respective country,
also if a less severe data protection law should exist.
We do not disclose information about you to anyone outside the organization without the above
consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your
personal information might be forwarded to the meeting location or the meeting organizer. Only
personal information relevant for the 3rd party will be disclosed in these circumstances.
Furthermore, your data can be transmitted to public databases for registration, as well as
publication of a trial and your data can be stored and published in those databases.
Storing and deleting your personal information:
For historical reasons and as your details might be saved in old attendance lists, email
correspondence and minutes from meetings, we cannot promise that all personal information
about you will be deleted, when you end your participation in a study. In general, all information
about a trial is deleted at least 20 years after end of study.

Your rights:
You have a number of rights via the General Data Protection Regulation (GDPR):
• The Right to Information (to be informed what information we process about you)
• The Right of Access (to get a print of the information we process about you)
• The Right to Rectification (to have false information about you corrected)
• The Right to Erasure (to delete information we process about you, however, information
already received cannot be deleted)
• The Right to Restriction of processing (under certain conditions, to have the processing of
your data restricted)
• The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us, however, the legality of the processing carried out
prior to e.g., a withdrawal will not be affected. If you submit a request to have your personal
information corrected or deleted, we will investigate whether the conditions are met and, in that
case, make changes or deletions as soon as possible and, if applicable, also notify our data
processors to do so.

If you do not believe that NSGO-CTU handles your data correctly, you can file a complaint with the
supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information
(www.datatilsynet.dk).

Revision of Privacy Policy:
We reserve the right to change the organization’s privacy policy. When we change privacy policy,
we also change the date and version number at the bottom of this document. In case of significant
changes, you will receive a notification.

The current privacy policy for NSGO-CTU is always available on our website.

Practice Areas

Privacy Policy for NSGO

NSGO treats personal information and complies with the laws and principles of good data processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO is the data controller and you can always contact the organization’s data protection officer:

Mansoor Raza Mirza

We treat the following personal information about members:

General personal information: For example, contact information such as name, work address, work phone number, private phone number, date of birth, email address, country, work title, date of membership, date of membership termination and cv in relation to membership application. Parts of credit card number via Epay and, if applicable, Bank account number for reimbursement purposes. When applicable, Board Members may be asked to give NSGO copies of other personal documents (for example passport or tax bill) in relation to the Danish Laundering Act.
Other information: For example, positions of trust, board membership and other duties in relation to the organization.

We collect personal information from:

Usually we will get the information from you, when you register to become a member of NSGO and when you apply for reimbursements or pay your membership fee

The organization’s legal basis to process personal information:

That we as an organization have a (legitimate) interest in processing your information
That it is necessary for us to fulfill an agreement with you
You have agreed that we can process your information via becoming a member of the

The purpose of processing personal information:

That we can run the organization’s activities, including planning, implementing and following up on them
To invite to vote for Board and President Elect elections
To distribute newsletters
To comply with legislation

To deliver services, in the form of the possibility to participate in the Annual Meeting, Investigator Meeting and if applicable Strategic Meetings, Board Meetings, Scientific Committee Meetings, Foundation Meetings.
To notify members about other Gynecologic Cancer Managing your relationship with the organization
To handle your membership rights
For you to fulfill your obligations as a member of the organization, including paying the membership fee, etc.
Being able to display situation images from a specific event in the organization for instance from NSGO Annual Meetings
To maintain historical value data for statistics and the like

Consent:

When you become a member, we have a legal basis to process your personal information for the (legitimate) interest of the organization. However, it may happen that we judge it necessary to obtain your written consent for other purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it at any time by notifying us.

Dispatch of your personal information:

We do not disclose information about you to anyone outside the organization without your consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your personal information might be forwarded to the meeting location or the meeting organizer. Only personal information relevant for the 3^rd party will be disclosed in these circumstances.

Storing and deleting your personal information:

For historical reasons and as your details might be saved in old attendance lists, email correspondence and minutes from meetings, we cannot promise that all personal information about you will be deleted, if you terminate your membership.

Your rights:

You have a number of rights via the General Data Protection Regulation (GDPR):

The Right to Information (to be informed what information we process about you)
The Right to Rectification (to have false information about you corrected)
The Right to Restriction of processing (under certain conditions, to have the processing of your data restricted)
The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us. If you submit a request to have your personal information corrected or deleted, we will investigate whether the conditions are met and, in that case, make changes or deletions as soon as possible and, if applicable, also notify our data processors to do so.

You can file a complaint with the supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information (www.datatilsynet.dk).

Revision of Privacy Policy:

We reserve the right to change the organization’s privacy policy. When we change privacy policy, we also change the date and version number at the bottom of this document. In case of significant changes, you will receive a notification.

The current privacy policy is always available on our website.

NSGO-CTU – The Clinical Trial Unit

Our Story

The Mission

The Purpose

NSGO-CTU Office

NSGO-CTU Leadership

NSGO-CTU Team

NSGO-CTU Address:

Call us:

Get in touch:

NSGO-CTU Bylaws

Foundation Governance

Foundation Committee

Scientific Committee

Translational Research Group

Mission Statement:

Objectives:

The main activities are:

Members:

Contact Info

Office Hours

Membership

Info

NSGO Address:

NSGO-CTU Address:

Visiting Address:

Privacy Policy for NSGO

Practice Areas

Newsletter

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