Study Overview Form

Study Workflow

XX Days Remaining to Reply

Approval Status

Fully Approved

Flo Bossperson

Quality Assurance

Nell Organs

GEE

Petra Mulley

Study Lead

Jack Williams

New

Originator Name DD/MM/YY

Document upload

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Part 1: Study Information (completed by study lead)

Study leader name*

Date of study outline submission*

Product name/code that study will support*

Product indication*

Proposed study title*

Planned study start date*

Planned study end date

Projected number of patients

Please list the countries and number of sites involved in the study, for example: Spain – 5 sites

Study rationale*

Study primary objectives

Study secondary objectives

Study exploratory objectives

Main questions this study is aimed at addressing

What do you intend the key scientific point(s) to be from doing this study

Study primary endpoints

Study secondary endpoints

Study exploratory endpoints

Study type*

Non-interventional / observational

Interventional with RWD component

Design*

Retrospective observational

Prospective observational

Hybrid

Please clarify if the retrospective data is chart review or a database study

Data collection*

Primary data

Secondary data

Hybrid

Primary data: Description of study sites

Secondary data: Name and description of the data source

Part 3: Vendor / Third Party Information (if applicable) (completed by study lead)

Vendor name

Vendor address

Vendor contact/s

Has this Vendor’s services been used by Shionogi before?*

Yes

Unknown

Please can you provide details of how long the Vendor’s services have been utilised by Shionogi below:

Would the Vendor be willing to complete a GCP/GVP-QA questionnaire?*
This is so that Shionogi can perform an internal QA assessment using the questionnaire responses provided by Vendor

Yes

Part 4: Study status (completed by study lead)

Actual study start date

Actual study end date

Date of submitting final study report to ERT

Date of informed PSMF (if applicable)

Execution of the publication plan

Yes

Link to the final publications

Abstract

Link

Posters

Link

Manuscript

Link

Other

Link

Quality Assurance Assessment (completed by QA)

Name:

Role:

Date of assessment:

Signature:

Approved

Impact GxP/GCP/GVP?

Reason for impact/non-impact

Future assessment required?

Approximate date of future assessment

* Denotes this field is mandatory and must be completed

Audit trail for this entry

22/02/2023 14:49:14 - RWE User 0 – Study created

Name	Position	Office	Age	Start date	Salary
Tiger Nixon	System Architect	Edinburgh	61	2011/04/25	$320,800
Garrett Winters	Accountant	Tokyo	63	2011/07/25	$170,750
Ashton Cox	Junior Technical Author	San Francisco	66	2009/01/12	$86,000
Cedric Kelly	Senior Javascript Developer	Edinburgh	22	2012/03/29	$433,060
Airi Satou	Accountant	Tokyo	33	2008/11/28	$162,700
Brielle Williamson	Integration Specialist	New York	61	2012/12/02	$372,000
Herrod Chandler	Sales Assistant	San Francisco	59	2012/08/06	$137,500
Rhona Davidson	Integration Specialist	Tokyo	55	2010/10/14	$327,900
Colleen Hurst	Javascript Developer	San Francisco	39	2009/09/15	$205,500
Sonya Frost	Software Engineer	Edinburgh	23	2008/12/13	$103,600
Jena Gaines	Office Manager	London	30	2008/12/19	$90,560
Quinn Flynn	Support Lead	Edinburgh	22	2013/03/03	$342,000
Charde Marshall	Regional Director	San Francisco	36	2008/10/16	$470,600
Haley Kennedy	Senior Marketing Designer	London	43	2012/12/18	$313,500
Tatyana Fitzpatrick	Regional Director	London	19	2010/03/17	$385,750
Michael Silva	Marketing Designer	London	66	2012/11/27	$198,500
Paul Byrd	Chief Financial Officer (CFO)	New York	64	2010/06/09	$725,000
Gloria Little	Systems Administrator	New York	59	2009/04/10	$237,500
Bradley Greer	Software Engineer	London	41	2012/10/13	$132,000
Dai Rios	Personnel Lead	Edinburgh	35	2012/09/26	$217,500
Jenette Caldwell	Development Lead	New York	30	2011/09/03	$345,000
Yuri Berry	Chief Marketing Officer (CMO)	New York	40	2009/06/25	$675,000
Caesar Vance	Pre-Sales Support	New York	21	2011/12/12	$106,450
Doris Wilder	Sales Assistant	Sidney	23	2010/09/20	$85,600
Angelica Ramos	Chief Executive Officer (CEO)	London	47	2009/10/09	$1,200,000
Gavin Joyce	Developer	Edinburgh	42	2010/12/22	$92,575
Jennifer Chang	Regional Director	Singapore	28	2010/11/14	$357,650
Brenden Wagner	Software Engineer	San Francisco	28	2011/06/07	$206,850
Fiona Green	Chief Operating Officer (COO)	San Francisco	48	2010/03/11	$850,000
Shou Itou	Regional Marketing	Tokyo	20	2011/08/14	$163,000
Michelle House	Integration Specialist	Sidney	37	2011/06/02	$95,400
Suki Burks	Developer	London	53	2009/10/22	$114,500
Prescott Bartlett	Technical Author	London	27	2011/05/07	$145,000
Gavin Cortez	Team Leader	San Francisco	22	2008/10/26	$235,500
Martena Mccray	Post-Sales support	Edinburgh	46	2011/03/09	$324,050
Unity Butler	Marketing Designer	San Francisco	47	2009/12/09	$85,675
Howard Hatfield	Office Manager	San Francisco	51	2008/12/16	$164,500
Hope Fuentes	Secretary	San Francisco	41	2010/02/12	$109,850
Vivian Harrell	Financial Controller	San Francisco	62	2009/02/14	$452,500
Timothy Mooney	Office Manager	London	37	2008/12/11	$136,200
Jackson Bradshaw	Director	New York	65	2008/09/26	$645,750
Olivia Liang	Support Engineer	Singapore	64	2011/02/03	$234,500
Bruno Nash	Software Engineer	London	38	2011/05/03	$163,500
Sakura Yamamoto	Support Engineer	Tokyo	37	2009/08/19	$139,575
Thor Walton	Developer	New York	61	2013/08/11	$98,540
Finn Camacho	Support Engineer	San Francisco	47	2009/07/07	$87,500
Serge Baldwin	Data Coordinator	Singapore	64	2012/04/09	$138,575
Zenaida Frank	Software Engineer	New York	63	2010/01/04	$125,250
Zorita Serrano	Software Engineer	San Francisco	56	2012/06/01	$115,000
Jennifer Acosta	Junior Javascript Developer	Edinburgh	43	2013/02/01	$75,650
Cara Stevens	Sales Assistant	New York	46	2011/12/06	$145,600
Hermione Butler	Regional Director	London	47	2011/03/21	$356,250
Lael Greer	Systems Administrator	London	21	2009/02/27	$103,500
Jonas Alexander	Developer	San Francisco	30	2010/07/14	$86,500
Shad Decker	Regional Director	Edinburgh	51	2008/11/13	$183,000
Michael Bruce	Javascript Developer	Singapore	29	2011/06/27	$183,000
Donna Snider	Customer Support	New York	27	2011/01/25	$112,000

Filename	Version	Uploaded/Edited By	Last Edited
Document name	3	Firstname Lastname	2022/MM/DD HH:MM:SS
Document name	2	Firstname Lastname	2021/MM/DD HH:MM:SS
Document name	1	Firstname Lastname	2020/MM/DD HH:MM:SS

Request Price	Current Ex-Factory Prices
	GILTERITINIB 40mg (90)
	£0.00

Section 1:

Section 2:

Study Overview Form

Study Workflow

Document upload

Part 1: Study Information (completed by study lead)

Part 2: Study result use (completed by study lead)

Part 3: Vendor / Third Party Information (if applicable) (completed by study lead)

Part 4: Study status (completed by study lead)

Review and Approval (completed by GEE)

Quality Assurance Assessment (completed by QA)

Audit trail for this entry

Request Price	Current Cost/Eq.Unit Ex-Factory

	0.00

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