Study documents

IRAS Project ID: 70980

Study title: Parkinson's Repository of Biosamples and Network Datasets: Prospective observational study of Parkinson's Disease with repeat clinical assessment and biobanking of blood samples (PRoBaND)

Study end date:31/12/2022

Study status: Closed

Study Closure 2023


Declaration of the end of a study		10/03/2023
REC acknowledgment of Declaration of end of study		19/04/2023

Site Archiving Certificate SPONSOR FORM 51.024C	2.0
Protocol deviation SPONSOR FORM 51.008A	3.0

Full extension 2016-2022

1.7	REC Ref AM06	Substantial amendment (07) 15/02/2017	APPROVED		21/03/2017
Re: Protocol				1.5	24/06/2016
Evidence of Sponsor insurance or indemnity (non NHS Sponsors only) [Insurance extension]					19/07/2016
GP/consultant information sheets or letters [GP Letter Recruitment of Relative for Extension - Clean]				1.2	27/06/2016
GP/consultant information sheets or letters [GP Letter Recruitment of Relative for Extension - Tracked Changes]				1.2	27/06/2016
GP/consultant information sheets or letters [GP Letter Recruitment of Patient for Extension - Clean]				1.2	27/06/2016
GP/consultant information sheets or letters [GP Letter Recruitment of Patient for Extension - Tracked Changes]				1.2	27/06/2016
Notice of Substantial Amendment (non-CTIMP)				1.7	15/02/2017
Other [Change of Principal Investigators]					18/01/2017
Other [Information about research results - Patients ]				1.0	27/06/2016
Other [Information about research results - Relatives]				1.0	27/06/2016
Participant consent form [Patient Extension Consent Form - Tracked Changes ]				1.2	27/06/2016
Participant consent form [Patients Extension Consent Form - Clean ]				1.2	27/06/2016
Participant consent form [Relatives Extension Consent Form - Clean ]				1.4	27/06/2016
Participant consent form [Relatives Extension Consent Form - Tracked Changes]				1.4	27/06/2016
Participant information sheet (PIS) [Patient Extension PIS - Clean]				1.2	27/06/2016
Participant information sheet (PIS) [Patient Extension PIS - Tracked Changes]				1.2	27/06/2016
Participant information sheet (PIS) [Relatives Extension PIS - Tracked Changes]				1.3	27/06/2016
Participant information sheet (PIS) [Relatives Extension PIS - Clean ]				1.3	27/06/2016
Research protocol or project proposal [Tracked Changes]				1.5	24/06/2016
Research protocol or project proposal [Clean ]				1.5	24/06/2016
HRA Approval					03/05/2017

Notification of non-substantial amendment [No cost extension 2020]					06/02/2020
Non-substantial amendment [No-cost extension] approval					11/05/2020

Notice of amendment NSA Aug 2020 [COVID-19]					21/08/2020
Remote assessment guidance [COVID-19]				1.0	10/08/2020
NRSPCC Approval NSA Aug 2020 [COVID-19]					25/08/2020
HRA and HCRW Approval NSA Aug 2020 [COVID-19]					25/08/2020

Notice of amendment NSA Apr 2022 [No cost extension 2022]					11/04/2022
NRSPCC Categorisation NSA Apr 2022 [No cost extension 2022]					14/04/2022
HRA and HCREW Approval NSA Apr 2022 [No cost extension 2022]					20/04/2022

Interim extension 2014-2015

	REC Ref AM05	Non-substantial amendment 10/04/2015	ACKOWLEDGED		10/04/2015
Re:Protocol				1.4	04/02/2015
Notice of Minor Amendment [E-mail]					10/04/2015
Participant consent form [Clean]				1.1	10/04/2015
Participant consent form [Track Changes]				1.1	10/04/2015
Participant information sheet (PIS) [Clean]				1.1	10/04/2015
Participant information sheet (PIS) [Track Changes]				1.1	10/04/2015

Initial phase 2011-2014

	REC Ref 11/AL/0163	CONDITIONALLY APPROVED		07/04/2011
Re: Protocol			1.0	16/03/2011
Protocol			52504/1	16/03/2011
Participant Information Sheet: Patients Diagnosed with Parkinson's disease in the past 3 years			1.0	16/03/2011
Investigator CV			1.0	16/03/2011
REC application			3.1	17/03/2011
Participant Information Sheet: Patients Diagnosed with Parkinson's 1.0 disease at under 50 years			1.0	16/03/2011
Participant Information Sheet: Relatives of patients with Parkinson's 1.0 disease			1.0	11/03/2011
Participant Consent Form: Patients diagnosed with Parkinson's in the past 3 years			1.0	16/03/2011
Participant Consent Form: Patient's diagnosed with Parkinson's disease at under 50 years			1.0	16/03/2011
Participant Consent Form: Relatives of patients with Parkinson's disease			1.0	11/03/2011
GP/Consultant Information Sheets			1.0	16/03/2011

REC Ref

11/AL/0163

Amendments to meet conditions of REC approval

14/07/2011

APPROVED

08/08/2011

Re:Protocol

1.1

27/04/2011

Protocol

1.1

27/04/2011

REC Ref 11/AL/0163	Modified amendment 20/12/2011	APPROVED		23/12/2011
Re:Protocol			1.2	28/10/2011
Modified Amendment			1.2	28/10/2011
Protocol [clear]			1.2	28/10/2011
Protocol [tracked changes]			1.2	28/10/2011
Reply sheet; Tracking Parkinson's			1.0	18/12/2011
Letter to patients in a local clinical service			1.0	18/12/2011
Expression of interest in the Tracking Parkinson's study			1.0	28/10/2011
Donor Information Booklet			Imperial
Summary of Proband changes				20/12/2011
Advertisement			1.0	18/12/2011
Questionnaire: BFI - Big Five Inventory
Questionnaire: Wearing Off Questionnaire
GP/Consultant Information Sheets			1.1	16/12/2011
Participant Consent Form Relatives of patients with Parkinson's disease [tracked changes]			1.2	28/10/2011
Participant Consent Form Relatives of patients with Parkinson's disease [clear]			1.2	28/10/2011
Participant Consent Form Patients diagnosed with Parkinson's disease at under 50 years of age [tracked changes]			1.2	28/10/2011
Participant Consent Form Patients diagnosed with Parkinson's disease at under 50 years of age [clear]			1.2	28/10/2011
Participant Consent Form Patients diagnosed with Parkinson's disease in the past 3 years [tracked changes]			1.2	28/10/2011
Participant Consent Form Patients diagnosed with Parkinson's disease in the past 3 years [clear]			1.2	28/10/2011
Participant information sheet Relatives of patients with Parkinson's disease [tracked changes]			1.2	28/10/2011
Participant information sheet Relatives of patients with Parkinson's disease [clear]			1.2	28/10/2011
Participant information sheet Patients diagnosed with Parkinson's disease at under 50 years of age [tracked changes]			1.2	28/10/2011
Participant information sheet Patients diagnosed with Parkinson's disease at under 50 years of age [clear]			1.2	28/10/2011
Participant Information Sheet Patients diagnosed with Parkinson's disease in the past 3 years [tracked changes]			1.2	28/10/2011
Participant Information Sheet Patients diagnosed with Parkinson's disease in the past 3 years [clear]			1.2	28/10/2011

	REC Ref 15/03/2012	Non-substantial Amendment 15/03/2012	APPROVED		19/03/2012
Re:Protocol				1.2	28/10/2011
Participant Consent Form: Patient diagnosed in the past 3 years				1.4	15/03/2012
Participant Consent Form: Patients diagnosed at under 50 years of age				1.4	15/03/2012
Participant Consent Form: Relatives of patients with Parkinson’s disease				1.3	15/03/2012

1.6	REC Ref AM04/1	Substantial amendment modified 25/02/2015	APPROVED		09/03/2015
Re:Protocol				1.4	19/02/2015
GP/consultant information sheets or letters [Clean]				1.0	25/02/2015
GP/consultant information sheets or letters [Track Changes]				1.0	25/02/2015
Notice of Modified Amendment				1.6	19/02/2015
Participant consent form				1.0	19/02/2015
Participant consent form [Track Changes]				1.0	19/02/2015
Participant information sheet (PIS) [Clean]				1.0	19/02/2015
Participant information sheet (PIS) [Track Changes]				1.0	19/02/2015
Research protocol or project proposal [Clean]				1.4	19/02/2015
Research protocol or project proposal [Track Changes]				1.4	19/02/2015

	REC Ref 11/AL/0163	Amendments to meet conditions of REC approval 27/04/2011	APPROVED		17/05/2011
Re:Protocol				1.0	16/03/2011
Consent Form : Patients diagnosed with Parkinson's disease in the past 3 years				1.1	18/04/2011
Patient Information Sheet : Patients diagnosed with Parkinson's disease in the past 3 years				1.1	18/04/2011
Consent Form : Patients diagnosed with Parkinson's disease under 50 years of age				1.1	18/04/2011
Patient Information Sheet: Patients diagnosed with Parkinson's disease under 50 years of age				1.1	18/04/2011
Consent Form : Relatives of patients with Parkinson's disease				1.1	18/04/2011
Information sheet : Relatives of patients with Parkinson’s disease				1.1	18/04/2011

1.3	REC Ref AM03-1	Substantial amendment 12/02/2014	APPROVED		25/04/2014
Re:Protocol				1.3	12/02/2014
Modified Amendment				1.3	25/04/2014
Protocol				1.3	12/02/2014
Relatives contact sheet				1.0	12/02/2014
Site record of patient contact regarding relatives				1.0	14/02/2014
Guides notes for involving relatives in the PRoBaND study				1.0	12/02/2014
L-dopa tests dose – Guides notes for patients				1.0	12/02/2014