STUDY ADMINISTRATION CODE 84140 DATE OF REQUEST

INTERNATIONAL PILOT STUDY ON THE EVALUATION OF
RESILIENCE IN THE FOOD CHAIN A STUDY
STUDY NAME OPTIONS ANALYSIS PREPARED BY NAME TITLE JOB

14 8BXXXE INTERNATIONAL TELECOMMUNICATION UNION RADIOCOMMUNICATION STUDY
14 CUSTOMS COOPERATION CASE STUDY FOR CANADA
283 FUENTE WWWITUINTITUDSTUDYGROUPS SGP20022006SG2133000S4DOC RESULTADO SUPLEMENTARIO

Retrospective Study: Analysis of unrelated donor stem cell transplantation

Study Administration Code 84140..........

Date of Request: .. / .. / ..

Date of approval Chair: .. / .. / ..

Survey request proposal for the

Infectious Diseases Working Party

IDWP chair:

Rafael de la Camara

Title of the survey:

(Please do not use more than 15 words)

Principal investigator:

(Name, department, hospital, city, country)

Background & Rationale:

(State why you think it is necessary to conduct this study in approx. 100 words; list references)

Short description of the study:

(Explain your proposal in approx. 150 words)

Primary objective:

(Describe the primary aim you intend to achieve with this study)

Secondary objectives:

Endpoint(s):

(Describe the endpoints for analysis)

Research design:

(Explain at what time-points during treatment and follow-up data will be asked for, e.g. at diagnosis, at transplant, at 6 months after transplant)

Including: Duration of the study

(date inclusion will start, estimation of date inclusion will be closed, length of follow up, can patients be included retrospectively and if so, define period)

Study Population:

(Expected number of centres/patients, diagnosis, type of transplant, age, period analysed, stem cell source, inclusion criteria, exclusion criteria)

Data Collection & Statistical Analysis Plan:

(List all research variables to be collected and list all outcome variables to be analysed, give a brief description of the method of analysis (in collaboration with the EBMT statistician).)

All data collection will be performed by the IDWP Data Office (Leiden) according to EBMT guidelines.

Study budget: ( when applicable)

(In case of funding from outside EBMT , please contact the Leiden Data Office to prepare a budget to negotiate with possible sponsors).

Purpose of your study request:

(Paper, Presentation, etc.)

Publication

The EBMT Authorship guidelines apply to this proposal.

Writing Committee

(list all people involved)

Approval

Signature WP chair

name:__________

____________

Signature Head Data Office Signature EBMT statistician

name:_______________________ name:_______________________

Please send this form to:

Nina Knelange – IDWP Study coordinator

E-mail: [email protected]

Leiden Study Unit, Infectious Diseases Working Party
Department of Biomedical Data Sciences
Postzone S-05-P
LUMC
PO Box 9600
2300 RC Leiden
The Netherlands
Faxnr: +49 711 4900 8723 (fax to e-mail system)

3 RADIOCOMMUNICATION STUDY GROUPS SOURCE DOCUMENT 4CTEMP42(REV1)
6 7BL13E INTERNATIONAL TELECOMMUNICATION UNION RADIOCOMMUNICATION STUDY
9 7D129 (ANNEX 3)E RADIOCOMMUNICATION STUDY GROUPS

Tags: 84140, request, study, administration