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Bowel Function Diary (BF-Diary)

Janssen Global Services, LLC (USA); Mapi

Distributed by Mapi Research Trust

Distributed by Mapi Research Trust

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Basic description

Developed in 2011

Authors

Janssen Global Services, LLC (USA); Mapi

Copyright
BF-Diary © 2011 Mapi Research Trust, All rights reserved
Objective
To capture comprehensively the relevant patient information about opioid-induced constipation (OIC) in a clinical trial setting.
Therapeutic area
  • Mental Disorders
  • Chemically-Induced Disorders
  • Pathological Conditions, Signs and Symptoms
  • Nervous System Diseases
  • Psychological Phenomena and Processes
  • Musculoskeletal and Neural Physiological Phenomena
Therapeutic indication
  • Opioid-Related Disorders
  • Constipation
  • Pain
Opioid-induced Constipation; Chronic Pain
Type of Clinical Outcome Assessment (COA)
  • PRO PRO
Composite measure
Original language(s)
  • English for the USA
Bibliographic reference(s) of the original questionnaire

Camilleri M, Rothman M, Ho KF, Etropolski M. Validation of a bowel function diary for assessing opioid-induced constipation. Am J Gastroenterol. 2011 Mar;106(3):497-506 (PubMed Abstract)


Contact and conditions of use

Authors

Janssen Global Services, LLC (USA); Mapi

Contact information

Mapi Research Trust
PROVIDE™
27 rue de la Villette
69003 Lyon
France
Phone: +33 (0)4 72 13 66 66

Conditions of use

Non-Commercial Users

If you do not receive specific funding for your study, you may download the questionnaire directly:

  1. Log in or Register for free
  2. Click the 'Online distribution' tab in the left menu bar and follow the instructions

Tutorials are available on our FAQs.

Commercial Users

All requests have to be submitted through our online request management:

  1. Log in or Register for free
  2. Submit your request (Tutorials are available on our FAQs)
  3. In order to accelerate the process, you may attach the User Agreement (even if not finalized) to your online request. Click the link below for the user agreement template.
  4. Our PROVIDE team will get back to you with the needed information in a timely manner

Access fees

ROYALTY FEES* Commercial users Cost per study Free
Cost per language Free
Funded academic research Cost per study Free
Cost per language Free
Not funded academic users Cost per study Free
Cost per language Free
DISTRIBUTION FEES* Commercial users Cost per study 1 250 €
Cost per language 625 €
Funded academic research Cost per study 300 €
Cost per language 50 €
Not funded academic users Cost per study Free
Cost per language Free

* Excluding VAT
Commercial users: Industry, CRO, any for-profit companies
Funded Academic research: Projects receiving funding from commerce, government, EU or registered charity. Funded academic research– sponsored by industry fits the “commercial users” category.
Not funded academic users, individual medical practice: Projects are not explicitly funded, but funding comes from overall departmental funds or from the University or individual funds

Note:

Mapi Research Trust’s distribution fees shall be paid for each study.

Conditions to translate

Please refer to the "Languages" tab

Conditions to implement in electronic applications

Exclusive licensor for e-versions of the questionnaireMapi Research Trust

Academic and Commercial Users
  • Shall follow the “Conditions of use”  mentioned above
  • In addition, in case the electronic version of the questionnaire is developed by a third party (IT Company, e-PRO vendor…), User shall check with Mapi Research Trust that this third party has signed the necessary License Agreement with Mapi Research Trust before developing the electronic version of the Questionnaire.

Information Technology (IT) Companies (incl. ePRO vendors)
  • In case of a one-shot development and commercial use of an electronic version of the questionnaire by the IT Company, the IT Company shall:
    • Sign a “Specific-Study License Agreement with IT Company” with Mapi Research Trust
      • authorizing the electronic implementation of the questionnaire for the specific study only
      • shall not permit the IT Company to promote the electronic version of the questionnaire or its use for another study or another client
    • Pay a one-shot license fee per study to Mapi Research Trust: 500 Euros
  • In case of an IT Company who wishes to develop an electronic version of the questionnaire and would like to obtain a non-exclusive license to market and promote their devices / tablets / smartphones / e-applications using the questionnaire, the IT Company shall:
    • Sign a “General License Agreement with IT Company” with Mapi Research Trust
      • authorizing the electronic implementation of the questionnaire on multiple devices for multiple studies and clients
      • permitting the IT Company to promote the electronic versions of the questionnaire by any marketing means (including, but not limited to, IT Company’s  promotional documents / websites / press release / communication during conferences / webinars)
    • Pay an annual administrative fee of 2,500 Euros to Mapi Research Trust

Review copy

Examination copies can only be used for the limited purpose of examining the suitability of the Questionnaire for subsequent research and/or clinical use, and cannot be used in research or in clinical practice or distributed to others.
You are not authorized to modify, retype, translate, copy or otherwise duplicate the Questionnaire except with the further and prior written permission of Mapi Research Trust / the developers / copyright holders / distributors.

Online distribution

For Non-Funded Academic Studies

The following licensing process is restricted to academic users:

  • Who do not receive specific funding for their study
  • Who intend to use the questionnaire in individual clinical practice or research study

Should you not correspond to this category of users, please send us a request.

Note: This site aims at providing you with the original version and existing translations of the questionnaire. However some modules/versions may not be downloadable in the language you need.

If you are interested in specific language(s), please first consult the list of existing translations in PROQOLID.

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To access this section, please complete a client account.

Languages

Original language(s)

  • English for the USA

Translations

The translations listed may not have undergone a full linguistic validation process and may require further work to be suitable for use in a study. This list is subject to constant changes, therefore please check the status of translations with Mapi Research Trust / the developers / copyright holders / distributors.

BF-Diary

French for Canada
Spanish for the USA

The author has selected Mapi as exclusive linguistic validation company to ensure the production of harmonized and consistent language versions.

For additional information on available translations of this instrument, or for a project involving new languages, please submit a request (tutorials available on our FAQs).

Conditions to translate

Academic Translation

If you wish to translate the questionnaire:

  1. Log in or Register for free
  2. Submit your request for translation online (Tutorials are available on our FAQs)
  3. Our PROVIDE team will send you a translation agreement along with Linguistic Validation Guidelines.

Commercial Users

Exclusive vendor for translation work for commercial users: Mapi

More information on translations

Please note that for any production of a new translation of the instrument a “Permission to Translate Agreement” shall be completed and sent to MAPI Research Trust

E-versions

Conditions to implement in electronic applications

Please refer to the "Contact and conditions of use" tab

Last update: May 2016
For additional information, please submit a request. More information in our FAQs.

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