NSGO-CTU

Nordic Society Of Gynaecological Oncology - Clinical Trial Unit

About NSGO-CTU

Nordic Society of Gynaecologic Oncology -
Clinical Trial Unit

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 and two Deputy Medical Directors, who are 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. Mansoor Raza Mirza has led the clinical trial unit for a decade and is also a Chief Oncologist at Rigshospitalet, Copenhagen University Hospital and Vice-President of ESGO.

Dr. Kristine Madsen (DK) & Prof. Kristina Lindemann (NO) are appointed Deputy Medical Directors to support NSGO-CTU’s Medical Director, Dr. Mirza in managing the Clinical Trial Unit.

NSGO-CTU collectively consists of:

  • The Medical Director, 
  • NSGO-CTU Foundation Committee, 
  • Two Deputy Medical Directors, 
  • The staff of the NSGO-CTU Office, and 
  • The NSGO-CTU Scientific Committee

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.

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.

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

Line Bjørge (Chair)
Norway

Ane Gerda Zahl Eriksson
Norway

Annika Auranen
Finland

Susanne Malander
Sweden

Trine Jakobi Nøttrup
Denmark

Trine Lembrecht Jørgensen
Denmark, Odense

Henrik Roed
Denmark, Rigshospitalet

Charlotte Aaquist Haslund 
Denmark, Aalborg

Nicoline Raaschou-Jensen
Denmark, Herlev

Kristina Lindemann
Norway, Oslo

Jenny Litfjeld
Norway, Bergen 

Elisabeth Berge Nilsen
Norway, Stavanger

 

Hanna Dahlstrand
Sweden, Karolinska

Susanne Malander
Sweden, Lund

Gabriel Lindahl
Sweden, Linköping

Anthoula Koliadi 
Sweden, Uppsala

Annika Auranen
Finland, Tampere

Sakari Hietanen
Finland, Turku

Maarit Anttila
Finland, Kuopio

Birute Brasiüniené
Lithuania

Kristina Ojamaa
Estonia

Mansoor Raza Mirza

Medical Director

Rigshospitalet, Copenhagen University Hospital

Kristine Madsen

Deputy Medical Director

Rigshospitalet, Copenhagen University Hospital

Rikke Krogh Andresen

Office Leader & PA to Dr. Mirza

Phone: +45 3545 3389

Adela Ioana Buda

Financial & Event Coordinator
Phone: +45 3545 3389

Johanne Hestvang

ENGOT & GCIG rep.
Project Manager

Phone: +45 3545 3378

Julie Ardenkjær-Kastrup

Project Manager

Phone: +45 3545 3378

Mia Sejer Donner

Contract Manager

Karen Stampe Petersson

Project Manager
Phone: +45 3545 3398

Sanne Nygaard Lindberg

Project Manager
Phone: +45 3545 3398

Stine Randeris

Project Manager
Phone: +45 3545 3372

Line Jensen

Project Manager
Phone: +45 3545 3372

Henriette Watson Hansen

Project Manager
Phone: +45 3545 3372

Student Assistants

Emilie Damm Garly

LEA STRANDLY BRANDT

Julie LYSGAARD VILLADSEN

Michael Richard Elliks

Tobias Mirza

Address

Nordic Society of Gynaecological Oncology
Department of Cancer Treatment , 9431
Rigshospitalet
Copenhagen University Hospital
Blegdamsvej 9
DK-2100 Copenhagen

Phone no.

Monday-Thursday 09.00-15.00
Friday 09.00-14.00

+45 3545  3311

NSGO-CTU INVESTIGATOR MEETING 2024

Copenhagen, April 18. - 19. 2024 Registration is open

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 NSGO Bylaws Amendment 1 April 2022

 

 Revised Bylaws. Previous version dated 12-03-2021. 1

 

  1. Name and Domicile

1.1. The name of the Society is: Nordic Society of Gynaecological Oncology (NSGO) here in after referred to as either “NSGO” or “The Society”. The official language of the Society is English.

1.2. Address of Society: NSGO – Clinical Trial Unit, Rigshospitalet, Copenhagen University Hospital, Department of Cancer Treatment 9431, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. The Society is registered in Denmark.

1.3. The NSGO Board may establish offices outside of Denmark. Such offices shall report directly to the NSGO Board.

  1. Mission

2.1. NSGO is a non-political, non-profit society. The mission of NSGO is:

2.1.1. To be a Nordic platform for individual professionals dedicated to the care of women with gynaecological cancer.

2.1.2. To work for improvements in the practice of prevention, diagnosis, treatment, and follow up of gynaecological cancer.

2.1.3. To promote and support basic and clinical research.

2.1.4. To promote education and training in gynaecological oncology in all its aspects.

2.1.5. To promote and support Nordic and international exchange, and friendship among professionals and societies active in gynaecologic oncology.

2.2. As means to fulfil this mission the Society shall:

2.2.1. Promote and conduct collaborative clinical trials, regarding gynaecological cancer.

2.2.2. Organize and coordinate conferences, meetings and collaborative activities.

2.2.3. Set Nordic Standards of Care for women with gynaecological cancer.

2.2.4. Set Nordic Guidelines for professional education and training in gynaecological oncology.

2.2.5. Establish co-operation and relationships with other international, national and regional organisations in this field.

  1. Membership

3.1. Full Membership is open to any individual in a Nordic country, who is professionally or scientifically active in the field of gynaecological cancer, and whose application for membership has been approved by the NSGO Board. The employees of the pharmaceutical industry can not be members.

3.2. The Society grants associate membership to individuals who do not meet the geographic criteria given in item 3.1. An associate member does not hold voting privileges.

3.3. Application for membership is sent to the Board. A list of new members should be sent out with the call for the General Assembly. Membership is activated when accepted by the NSGO Board.

3.4. The Society has to keep a member registry. It is the member’s own responsibility to provide correct information about address, e-mail and telephone number.

3.5. Resignation from the Society is announced by the member to the NSGO Office. Membership will automatically be terminated after a reminder has been sent out if the annual membership fee has not been paid for two years.

3.6. Membership can be suspended if a member has done harm to the interests of the Society. Decision of suspension is made by the General Assembly after recommendation from the Board. A member, who has been suspended, can reapply for membership via the General Assembly.

  1. The General Assembly

4.1. The General Assembly is constituted by all members, and shall be the supreme governing body of the Society. The General Assembly shall meet at least once a year. Only full members present at the meeting have the right to vote. The General Assembly must be finally called, and the agenda for the General Assembly must be notified to the members by the President at least 2 weeks prior to the meeting by e-mail. 

 

4.2. Proposals for the General Assembly should have been received by the NSGO Office at least 4 weeks before the meeting. The first call to the General Assembly must be sent out by e-mail at least 6 weeks in advance.

4.3. The agenda for the General Assembly should include: 1. Opening of the meeting. 2. Election of chairman of the meeting. 3. Inquiry whether the call has been done in due order, according to bylaws. 4. Election of meeting secretary. 5. Election of two persons besides the chairman to check the minutes. 6. The Presidents annual report. 7. The Treasurers annual report of accountancy and final accounts. The accountants report. 8. Inquiry of adoption of the accounts and the report, and discharge of liability of the Board for the year. 9. The Presidents report of planned activities. 10. Presentation of a Budget for the coming year. 11. Approval of the Budget and determination of the annual membership fee. 12. Approval of election of new NSGO Board members 13. Approval of election of President Elect. 14. Installation of new President. 15. Election of nominating committee. 16. Other questions. 17. Closure of the meeting.

4.4. All matters at the General Assembly are decided by majority voting, if not dictated otherwise in the bylaws. The written and signed minutes of the General Assembly should be sent to the members by e-mail within two months from the meeting, and kept safe.

4.5. An Extra Ordinary General Assembly can be called by the Board, or if there is a written request, supported by at least 10% of the members for such an action.

  1. Bylaws Amendments

5.1. Proposals for amendments to the bylaws of the Society must be submitted in writing to the President not later than 3 months prior to the General Assembly. Such proposals must be included as an item on the Agenda and should be available to the members two (2) weeks before the General Assembly.

5.2. Adoption of amendments shall require the approval of not less than two-thirds (2/3) of full members present at the General Assembly.

  1. The Executive Board, the President and President Elect / Vice President

6.1. The affairs of The Society shall be governed by an Executive Board (hereafter called “the Board”) who shall act in its own best judgment and discretion to carry out the general Mission of The Society as governed by the Bylaws, established Policies, Procedures, General Assembly decisions and applicable law.

6.2. The Board shall institute standing and ad-hoc committees as required to conduct the business of the Society.

6.3. The Board shall consist of fourteen (14) Board members with at least two (2) representatives from each of the five Nordic Countries, a President and a Vice President.

6.4. The term of office for the elected Board members is two (2) years. Board members can be reelected for one additional 2-year term.

6.4.1. where few possibilities for new members as Physicist, Pathologist or Board members the term of office can be extended.

6.5. Nomination of Board candidates.

6.5.1 A Nominating Committee is appointed by the preceding General Assembly. The Nominating Committee requests written (by e-mail) member proposals of candidates for the Board, and contacts the potential candidates to get their consent. The Nominating Committee thereafter prepares a list including all proposed candidates to the Board. The list is sent to the Board before December 1st, the year before the elections.

6.5.2 The list of candidates for the Board is presented on the NSGO web site, and is also sent out to the members by e-mail at latest by January 5, the year of election.

6.6. Election of New Board Members

6.6.1 New members of the Board are elected by an online internet voting procedure via a password protected voting template on the NSGO web site. The web site should be open for online voting during at least 4 weeks, with beginning in the second week in January the actual year. The whole online voting procedure including any repetitive voting should be completed before March 1st.

6.6.2 The received votes should be formally counted under supervision by a voting committee, composed of the two past Presidents. From each Nordic Country the two (2) candidates receiving most votes are elected. If two candidates get equal number of votes, an additional NSGO Bylaws Amendment 1 April 2022

Revised Bylaws. Previous version dated 12-03-2021. 3

 

The election round between the two, have to be carried out online, during at least 2 weeks. This second round should also be completed before March 1st.

6.6.3 – The result of the election should be announced at, and the voting process should be officially approved by the General Assembly

6.7. The Society should always have a President, who presides over the Board and Board Meetings, and who is the legal representative of the Society in all matters. The Society should also have a President Elect serving as Vice President. It is recommended that President Elect should not represent the same country as President represents.

6.8 Election of President Elect.

 

6.8.1 A President Elect shall be elected by an online internet voting procedure via a password protected voting template on the NSGO web site, following the same procedures and time schedule as the Board elections, defined above.

6.8.2 In case there is only one candidate for the president elect position the NSGO board has the mandate to appoint the candidate as the next President Elect.

6.8.3 The result of the election should be announced at, and officially approved by the General Assembly.

6.9. The President Elect shall serve as Vice President. The term of office of the Vice President is three (3) years.

6.10. After three years term of office as Vice President, the President Elect shall be automatically installed as President. The term of office of the President should be three (3) years, with no direct re-election. The President can be re-elected once at a later occasion according to the procedure above.

6.11. Three years before the resignation of the President, a new President Elect should be elected.

6.12. Nomination of President Candidates.

6.12.1 The Nominating Committee requests written (by e-mail) member proposals of Candidates for President Elect, and contacts the potential candidates to get their consent. The Nominating Committee thereafter prepares a list including all proposed President Elect candidates. The list is sent to the Board before December 1st, the year before the election. The list of candidates for President Elect is presented on the NSGO web site, and is also sent out to the members by e-mail at latest by January 5, the year of election.

6.12.2 The result of the election should be announced at, and the voting process should be officially approved by the General Assembly.

6.13. Authority. Actions of the board shall be considered taken upon majority approval of the voting

ordinary members of the Board at a meeting. In the case of a vacancy in the office of the President, the Vice President shall assume this office and shall serve for the unexpired term of the President. Decisions are taken by simple majority of the votes, on condition that a minimum of four (4) Board members are present. Whenever a vote ends undecided, the President has the casting vote.

6.14. The Board has the obligation to create written minutes and decision protocols from Board meetings, and to keep them safe and available for NSGO members and accountants.

6.15. The Board constitutes itself with Secretary, Treasurer and decides it’s own agenda.

6.16. Any elected Board member may be removed from office at any time by a majority of at least ten (10) voting members of the Board whenever in its judgment the best interest of The Society will be served.

  1. Economy. Accountancy. Review

7.1. The financial year shall be closed every year on 31 December. The Board has the obligation to submit every year the accounts of the past financial year and the budget for the coming year for approval to the General Assembly.

7.2. The Society’s resources include annual membership fees and other incomes to the extent that can be achieved.

7.3. All members shall pay annual membership fees fixed by the General Assembly. Fees shall be paid to NSGO immediately upon election as a member of the Society, and thereafter as part of registration for NSGO Annual meeting or before 1 February every year.

 

7.4. The activities of the Board and the accounts and financial status of the Society shall be subject to annual audit by two accountants appointed by the General Assembly. The accountants are elected for one year. They can be re-elected.

7.5. An review of the Society’s accounts and finances shall also be made annually by a certified public accountant. It will be presented to the NSGO Board, and a copy will be made available upon request to any member of the Society.

7.6. Profit and excess amounts of the Society shall be used according to the mission of NSGO, or be placed at an NSGO account.

7.7. The assets of NSGO shall be kept at an account with annual interest rate.

  1. Authorized Signature. Liability.

8.1. The Society is validly represented in all matters or transactions by the signature of the President, who is responsible to the Board.

8.2. The Treasurer or the Executive Administrator will be allowed the autonomous decision in economical transactions up to a certain limit. The extent of this responsibility will be determined by the Board.

8.3. The Board can assign individual or collective commission to defined Board members.

8.4. The liabilities and obligations of the Society may be enforced against its assets only, and no member shall have any individual liability for any liabilities or obligations of the Society. A member’s liability vis-à-vis the Society is limited to the membership fees fixed by the General Assembly.

  1. Existence of Conflict.

9.1. Disclosure. A conflict of interest may exist when the direct, personal, financial interest of any Board member competes with, is adverse to, or diverges from the interests of The Society. If any such conflict of interest arises with regard to a matter requiring action by the Board, or if a member retains a significant financial interest, which may reasonably appear to be affected by an action of Board, then the interested party shall disclose such interest to the Board.

9.2. The Board shall determine if any such conflict exists and, in particular, the Board shall determine the specific interests of The Society at issue. The Board shall not deem a conflict of interest to exist, if standing alone, a Board member also serves as a director, officer or member of a non-profit or charitable organization, which solicits or receives funds from institutions or individuals from which The Society also solicits and receives funds.

9.3. Non-participation in Vote. If the Board determines that a member has a conflict of interest with respect to a certain action, hereinafter referred to as “Conflicted Member”, then the Conflicted Member shall not vote on or participate in the final deliberation or decision regarding the matter under consideration. The Conflicted Member, in addition, shall not be present during such deliberation, discussion or vote, unless requested by the Board to discuss, prior to the Board’s deliberation, any relevant information.

9.4. The minutes of meetings of the Board shall reflect that the conflict was disclosed. Also, minutes shall indicate that the Conflicted Member was not present during the final discussion or vote on a particular matter and that he did not participate in deliberations or vote on such action or issue.

  1. Reimbursement.

10.1. Members of the Board and other officers of the Society are expected to act on a voluntary basis, having their expenses related to NSGO activities reimbursed.

10.2. Additional reimbursement can be granted in case of extraordinary commitments for special tasks. Any person may be paid such compensation for services rendered to The Society in his/her capacity as a member of the Board, or officer, employee or otherwise, as the Board shall deem reasonable.

10.3. Such compensation may preferably be claimed and approved by the Board in advance.

  1. Dissolution of NSGO.

11.1. The Society shall be dissolved if a resolution to this effect is supported by not less than two thirds of the members present and voting at the annual or an extra General Assembly. If the majority but less than two thirds (2/3) of the present members at the General Assembly vote for dissolution of the Society, the proposal should be sent out by mail for a postal ballot voting procedure.

11.2. Proposals of dissolution of NSGO must be submitted in writing to the Board not later than three (3) months prior to the General Assembly. A proposal from the board for such a resolution should be sent out to the members with the Call to the General Assembly at least two (2) weeks before the meeting. 

 

11.3. Any assets remaining after the satisfaction of all debts and liabilities shall not be paid to, or distributed among the members of the Society, but shall be turned over to one or more non-profit corporations, funds or foundations engaged in medical research devoted to gynaecological cancer, to be designated by a majority of the Board holding office at the time of dissolution.

Helsinki 1 April 2022

Line Björge Annika Auranen Caroline Lundgren

President NSGO Chairman General Assembly Secretary General Assembly

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

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
Mansoor.Raza.Mirza@regionh.dk.

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 3rd 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.

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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
Mansoor.Raza.Mirza@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.

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