Legal Notice and Privacy Policy :

AERCHB - LiverMetsurvey

Version 2.0

Latest update: May 2008

     I.     Legal Notice

This page describes the legal instructions which apply to every Internet-user visiting this site. In consulting this site you undertake to respect these instructions without reservation. We advise you to consult these instructions regularly, as they may be modified from time to time and without notice.

  1. The website and intellectual property

The web site is located at : https://www.livermetsurvey.org/ (hereinafter the "Site").

This Site is owned and operated by :

AERCHB 

Association pour l’Enseignement et la Recherche en Chirurgie Hepato-Biliaire

Centre Hépato-biliaire – Hôpital Paul Brousse

94 804 Villejuif Cedex

The presentation and each of the materials posted on the web site located at https://www.livermetsurvey.org/ are protected by the applicable laws as regards Intellectual Property, and are owned by AERCHB, or have been subjected to authorisation of use granted to it. The logo and domain names are owned by SANOFI-AVENTIS.

Any material, information (written or oral) and any unpublished documentation provided to the physician participating in the study (or to a company acting for him), including this protocol, data recording forms and questionnaire, are the exclusive property of AERCHB. These material and information will not be provided or disclosed, completely or partially, to any unauthorised third party by the participating physician or anyone working under his responsibility, without preliminary written AERCHB agreement.

All authorized use of visuals, whether constituting the site or included within it, must not be distorted, modified or altered in any way whatsoever.

The data from this registry will be published on a regular basis. Each centre data are the property of the centre, but the participation in this study mandated an agreement to publish the aggregated data. A six-monthly report will be edited under the control of the Scientific Committee. The aggregated data will be published only with the agreement of the Scientific Committee which defined the publications rules and the authors list, depending upon the number of patients included in the registry, the contribution in the analysis and data review. Periodical reports will be made available for the participating centres and the organisms participating in this project. They may ask for additional analysis if the Scientific Committee agrees with them, and if they support them financially.

AERCHB reserves the right to take legal action against any counterfeit of its intellectual property rights.

  1. The aim of the Site

LiverMetsurvey is an international registry. Institution Based Registry: descriptive, observational, retrospective and prospective, multicentric, international, study performed in surgery fields taking care of patients with hepatic metastasis, on all the patients of each centre who underwent surgery for hepatic metastasis of colorectal origin. This prospective and retrospective data collection includes all patients who underwent surgery for resection of hepatic metastasis of colorectal origin whether the hepatectomy was performed or cancelled during the operation (Intention to Treat). This study is made of a principal prospective part and, to get an information basis from the study start, an optional retrospective part which is analysed separately.The information is collected during the patient’s inclusion in the study (at the time of the surgery for metastasis), and during the follow up for each patient, with no time limit. The centres participation only depends upon their willingness to participate, not taking into account previous experience or centre importance, in order not to bias the recruitment. Surgical resection being currently the determining factor for survival, surgery represents a necessary track for these patients.

The study LiverMetsurvey is set up through an on line Internet application. This method improves the quality of the data through on line data entry help and controls. It provides real-time management and edition of on-line statistics, and facilitates the communication between investigational sites, the coordinating centre and the Scientific Committee.

The LiverMetsurvey Site therefore collects data coming from International centers of

surgery for hepatic metastasis willing to participate.

  1. Investigators selection

Participating centres are surgery centres or multi-disciplinary centres with a surgery department. A mail is sent to the heads of surgery departments in charge of hepatic metastasis known by the Scientific Committee, and information are provided during surgery Meetings first in France then elsewhere in order to inform the centres not directly contacted. The centre participation is validated under the responsibility of the Scientific Committee, and requires the following:

 - The commitment to name a physician responsible for the study in the centre,

 - The commitment to exhaustively include patients,

- The capacity to follow the patients and to report their data directly on the internet site of the registry,

- The willingness to answer questions from the data manager and from the quality control,

- The commitment to follow the IT security procedures and the site confidentiality procedures. In order to assess the representativity, reasons for site refusal, whether because of the sites or because of the Scientific Committee, to participate will be recorded. To participate in the study, the prospective collection of data is mandatory, the retrospective data collection is optional. Lacking an exhaustive data base about centres taking care of hepatic metastasis, it is not planned to control the representativity of centres on a geographic basis or according to the activity in surgery of hepatic metastasis.

The potential centres known by the Scientific Committee are contacted by AERCHB by mail. This mail presents the objectives of the study, the protocol, the data reporting procedures, the investigator responsibilities (inclusion of all patients, patient information, exhaustive data collection during the whole study period, …)

The registration of a centre and its principal investigator is realized via a formulary on the LiverMetSurvey website. Personal identifiers will be given to the principal investigator via automatic email:

·        A user name

·        A personal password

·        A centre-specific password that allows other co-investigators from centre to join the LiverMetSurvey

The assigned personal password can be changed at any time by using the “management” menu.

The principal investigator must send both CV and registry participation agreement (available at www.livermetsurvey.com and provided as an attachment to the email providing your login and personal password) to the data manager. After confirmation of your registration from the data manager, you can begin to add patient data to the registry, as well as to manage the registration of co-investigators at your centre.

The enrolment of a co-investigator or a member of the centre’s team requires the principal investigator to provide him with the centre-specific password. The data manager will then confirm the registration of the co-investigator. If the principal investigator wants to close a co-investigator profile, this request should be sent via e-mail to the data manager.

  1. Access to the Site and the data

There is 2 parts:

- One part with a free access presenting the project

- One part with a reserved access, concerning data entry, data display, and the analysis of the registry.

The free access part provides information about the philosophy and interest of the project, and allows visitors to ask to join the project, after having agreed in writing to follow good practices including data use. Some general results and the list of participating centres are also available.

The access to the second part requires a login and a password.

When connected, the centre to which the user belongs is identified by the server. The user has access to:

- the patient data of his centre

- the statistics of his centre

- the data control of the patients

- the global Metsurvey statistics

- Several requests to follow the patients

- All documents of the study

- The management of his centre

- Export the data

In any case, he has no access to information regarding patients or statistics for the other centres. An audit trail identifies the time, date and author of data entry or data correction.

The LiverMetSurvey registry is secured with a SSL protection. The data are encoded between your computer and the server. They are deciphered only on the server.

  1. Use of the Site

The investigator may access the patient file via a list or search on lastname, first name, gender, birth date, patient code in centre and/or status (dead or alive). He then may look at the history of the events for one patient. He may access each event and look at the corresponding parameters.

The authorised users of one centre may correct or complete the data of the centre. It is possible to print the patient file and, if necessary, the audit-trails of the modifications. A validation plan for the data define online and/or offline controls for each variable. The on line controls are blocking (the field has to be completed and/or the inconsistent data have to be amended) immediately or non-blocking (the correction may performed later). The application functional analysis defines the way the modules have to be completed and if they may, even temporarily, not be completed. The data-manager may perform additional controls, edit the data, edit information requests then perform himself if necessary the corrections justified by the investigator.

At any time, the user may recover in text format all the data about a patient, i.e. a chronological description of all the events of a patient, with a summary and lay out. He may, in the same way, recover all the data of his centre in an Excel-compatible format.

  1. Medical advice disclaimer

This is an observational study, with no change in the usual medical management of people participating in the study, with no risk regarding physical or psychical integrity, and with no need of a specific study follow up visit. In these conditions, for France, this study is not part of the application field of articles L.209-1 and following of the Public Health Code (Code de la Santé Publique) and therefore doesn’t need any filing to a CCPPRB (Comité Consultatif pour la Protection des Personnes dans la Recherche Biomédicale).

The study protocol doesn’t change at all the usual medical management of the patient. The procedures described in this protocol, regarding the management, assessment and documentation of the study are organised for the AERCHB and the investigating physician to comply with the ethical principles defined in the declaration of Helsinki. The study will be performed in accordance with the « Loi Informatique et Libertés du 6 janvier 1978 modifiée par la loi du 1er juillet 1994 et complétée par un décret d’application le 9 mai 1995 ». The study is performed in accordance with the « article L.365-1 et à l’article L.462 du Code de la Santé Publique ».

In accordance with the french law " Loi Informatique et Libertés du 6 janvier 19", you have a right to access, to modify, to rectify and to suppress any personal data concerning you, simply by requesting it:

On line at :

livermetsurvey@manettis.com

By post at :

AERCHB

David Delvart

Centre Hépato-biliaire – Hôpital Paul Brousse

94 804 Villejuif Cedex

  1. Warranties and liabilities

In agreement with the French Law about trials not included in the Huriet Law field, no insurance policy is requested.

You acknowledge that (i) it is technically impossible that the Site will be provided free of defaults and that AERCHB cannot take any responsibility for this, (ii) that defaults may lead to the temporary unavailability of the Site, and that (iii) the operation of the Site may be adversely affected by conditions and performances outside AERCHB ‘s control, such as, for example, transmission and telecommunication links between AERCHB and you and between AERCHB and other systems and networks.

AERCHB may, at any time, temporarily or in permanently modify or interrupt, all or part of the Site in order to perform maintenance work and/or make improvements and/or changes to the Site. AERCHB is not liable for any modification to or suspension or interruption of the Site.

AERCHB makes every effort to ensure to the best of its abilities the accuracy and updating of the information broadcast on the Site, whose content the company reserves the right to change at any time and without prior notice. Nonetheless AERCHB cannot fully guarantee the accuracy, precision, updating or exhaustiveness of the information made available on the Site. As a result, and with the exception of direct damage resulting from wilful misconduct or gross negligence by AERCHB, the latter cannot be held liable for:

          • any imprecision, inaccuracy or omission relative to the information provided on the Site;

          • any damage resulting from fraudulent intrusion by a third party leading to the modification of the information or materials provided on the Site;

          • in a more general way, any damage, direct or indirect, regardless of its cause, origin, nature or consequences, even whilst AERCHB

          has been aware of the possibility of such damage, whether it be the result of (i) access or inability to access the Site, (ii) the use of the Site, including any damage or virus which may infect your computer system or any other product, and/or (iii) credit given to any information provided directly or indirectly by the Site.

The materials in the Site and all other sites are provided "as is", without any kind of warranty, whether express or implied. AERCHB does not offer any express or implied warranty relative without limitation to their merchantability and fitness for a particular purpose.

  1. Links to other sites

The responsibility of AERCHB will not be called into account with regard to any third-party site to which you may have gained access via the Site. We have no way of controlling the content of these third-party sites which remain totally independent of AERCHB. In addition, the existence of a link between the Site and any third party site in no way implies that AERCHB in any way approves of the content of this site, or, moreover, any use to which such content may be put.

Furthermore, it is your responsibility to take the necessary precautions to prevent the Site being contaminated by, including, but not limited to, one or more "viruses", "Trajan horses" or any other "parasites".

External sites may contain hyperlinks leading to the Site. Any such hyperlink shall not be installed without AERCHB ‘s express prior consent. In any case, AERCHB is in no way responsible for the unavailability of such external sites and AERCHB does not review, control, approve, nor is it responsible for any content, advertising, products or other materials available on or accessible via those sites.

  1. Copyright

The following notice shall appear on all copies of whole or part of the content of the Site:

"© AERCHB 2005-2011".


 II.     Privacy Policy

  1. Personal data protection

The use of nominative data is essential in order to avoid doubles and to be able to follow up the patients. It allows any participant of one center to unequivocally identify a patient, to look for information regarding patients lost to follow up, and to take into account patients transferred from one centre to another one. For France, AERCHB sent the study file to the « Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé » for advice and to the CNIL (Commission Nationale Informatique et Libertés) for an authorization to use computerized data collection.

Indirectly nominative data (initials, date of birth) about the patients are collected in agreement with the « Loi Informatique et Libertés du 6 janvier 1978 modifiée par la Loi du 1er juillet 1994 et complétée par un décret d’application le 9 mai 1995 ». The patient will be informed, in a way he can understand, of this study objective as well as his rights of access, rectification of his data. The patients will be informed that their data will be treated respecting confidentiality and professional secrecy.

The LiverMetSurvey registry is secured with a SSL protection. The data are encoded between your computer and the server. They are deciphered only on the server.

In accordance with the french law " Loi Informatique et Libertés du 6 janvier 1978", you have a right to access, to modify, to rectify and to suppress any personal data concerning you, simply by requesting it:

  1. Patients information

- Prospective arm:

The investigator will inform the patient during the visit. Each patient will receive an information notice.

- Retrospective arm aimed to have an information basis from the study start:

For the patients completing inclusion criteria and operated before 01/01/2005, the information about the computerized data treatment of scientific data will be given to all alive patients. For this purpose, a patient information notice is planned. In this notice, the study nature and objectives, as well as the patient rights of access, rectification and suppression of their data are explained.

© AERCHB 2005-2011      Legal Notice     powered by  Manettis
Update: 10/09/2016