POSE Trial Statistical Analysis Plan

TSAP_POSE_Version_1_2

TSAP_POSE_Version_1_2_Amendment

Secondary analyses documents

POSE SecondaryAnalysis_Guideline Sept 2020_V2.0 final

POSE SecondaryAnalysis_Study ProposalDocument_ V2.0_final

End of study documents

• POSE End of study reporting form 3.0 please send this completed form back to us, after study completion in your centre!
• POSE Task Delegation Form please send this completed form back to us. All persons listed in this form will receive a study participation certificate at the end of the trial.
• POSE Screening List Please enter here all patients, which you have screened during your recruitment period and who met the inclusion criteria, but you failed to capture them (e.g. logistics problem, consent mandatory but not signed, patient refused study participation etc.) and all your patients, which you have successfully included in the study. Please send this completed form back to us, after study completion in your centre!

Other documents: 

• POSE Confidential Patient log sheet this is only for your use, you don’t have to send it back to us!
• POSE Approval Documentation Coversheet

Actual version of the Study Protocol documents (English):

• Study protocol POSE study protocol final version 2.0
• Study protocol POSE study protocol final version 2.0 changes highlighted red
•  Appendix 1 Prestudy questionnaire
•  Appendix 2 POSE Case report form version 1.4 15.01.18
•  Appendix 3 Mini-Cog
•  Appendix 4 Timed Up & Go test_revised 14.12.17
•  Appendix 5 Study flowchart final version 1.0

Mini-Cog other languages:

• Portuguese Mini-Cog
• German Mini-Cog
• Spanish Mini-Cog
• Hebrew Mini-Cog
• DUTCH Mini-Cog

Further Mini-Cog translations are welcome!

Guidelines:

• Guideline_Local_Principle_Investigator_Role 
• Guideline_National_Coordinating_Investigator_Role
• POSE Guideline for phone interview 
• POSE Glossary Version 2.0
• POSE eCRF OpenClinica Guide Version

New General Data Protection Regulation (GDPR) for centres in the EU: 

• Became applicable on 25^thMay 2018 for all centres participating in POSE only from the European Union!
• Considering the updated data protection rights provided for patients in the GDPR, future patient information sheets and consent forms must be adapted to the requirements of the GDPR.

Applicable to: 

• All centres form the European Union, which were recruiting around 25^thMay 2018 or had patients in the follow up period after 25^thMay 2018.
• All centres, which already have an ethical approval and have actually started or plan to start their recruitment after 25^thMay 2018.

New-Data-Protection-Info-for-Investigators_29.08.18 please send us back the signed second page, if the new GDPR is applicable for your centre. 

POSE New Information About Data Privacy Rights for Study Subjects

POSE Data Protection-Log

German documents: 

POSE_DSGVO-Info-Patienten_german

POSE Data Protection-Log_german

Older versions of the Study Protocol documents (English): 

• Study protocol POSE study protocol final version 1.1 29.06.17
• Study protocol POSE study protocol version 1.1_tracked changes in RED
• Study protocol POSE study protocol final version 1.0
•  Appendix 2 POSE Case report form final version 1.0
•  Appendix 2 POSE Case report form version 1.1 29.06.17
•  Appendix 2 POSE Case report form version 1.2 17.09.17
•  Appendix 2 POSE Case report form version 1.3 31.10.17
•  Appendix 4 Timed Up & Go test

Older versions of the Trial statistical analysis plan

TSAP_POSE_Version_1.0

TSAP_POSE_Version_1.1

TSAP_POSE_Version_1.1_Amendment