Request Status: Submitted

Service Request

Principal Investigator / PI Delegate

(Only 1 Principal Investigator and Maximum 2 PI Delegate)

Role

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Principal Investigator / PI Delegate

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Project Information

IRB No.

12345678

Protocol Study Name

Protocol Study Name Protocol Study Name Protocol Study Name Protocol Study Name

Protocol No.

12345678

Expected Study Start Date

2020-01-20

Expected Study End Date

2021-06-20

Final Report date

2021-06-20

Primary Disease/Condition

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Type

Observational / Registry

Study Phase

Phase I

Intervention Type

Medicinal Products

Advanced Therapy Products

Allocation

Randomized

Estimated total number of subjects

IRB Application Form

application-form.pdf

Protocol Document

protocol.pdf

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Medicinal Product / Clinical Procedure

All the medicinal product(s) are approved/allowed for marketing in Hong Kong

Yes

All the medicinal product(s) will be used according to their labelled instruction

Yes

Involving Clinical Procedures(s)/Assessment(s) not needed for subjects’ normal case

Yes, Invasive

Based on the study information provided above and HKU’s policy, the need for a Clinical Trial Insurance is: MANDATORY

Estimated No. of Subjects Recruited from HKW cluster

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Contract Service

Organization Information and Contact Person

Supporting Organization Name

Li Ka Shing Faculty of Medicine

First Name

Poon

LasT Name

Lee

Salutation

Prof.

Title

Prof.

Address

21 Sassoon Road, Pokfulam, Hong Kong SAR

Telephone No.

3917 9175

Fax No.

2917 9175

Email Address

poonlee@ha.org.hk

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Agreement / Contract

Contribution by the supporting Organization

Medicinal product(s)

Ownership of study data and results

Investigator / HKU

Ownership of intellectual property/knowhow

Investigator / HKU

centre(s) to be coordinated by HKU

Multi Centres

Study Site

City, Country

Subject Recruitment Target (digit, >0)

Role

Study Site

Territory Coordinator

Principal Investigator

Name

Email Address

Primary Contract for Contract Negotiation

Name

Email Address

HKU

Hong Kong

Yes

Chun Kit

chunkit@hku.hk

Poon

poonwa@ha.org.hk

Study Site

HKU

City, Country

Hong Kong

Subject Recruitment Target (digit, >0)

Role

Study Site

Yes

Territory Coordinator

Subject Recruitment Target (digit, >0)

Name

Chun Kit

Email Address

chunkit@hku.hk

Primary Contract for Contract Negotiation

Name

Poon

Email Address

poon@ha.org.hkpoonwa01

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Document Upload

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Electronic Data Capture (REDCap) Service

All new REDCap service has “Under Development” REDCap status while you are building and testing the database. While you are ready to enter real data, you are required to make another request later to change the REDCap status to “Live”.

I have have read and agreed with the Terms and Conditions for REDCap Service.

REDCap Information & Member

REDCap Short Name (as REDCap project title)

REDCap Short Name

Primary Purpose

Treatment

Masking

Single-arm

ClinicalTrials.gov Identifier

12345678

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REDCap Member

Email Address

Portal User ID

Last Name

First Name

Type

Training Status

Study Role

poonwa@ha.org.hk

poonwa01

Poon

Type 2

Not completed

Builder & SC

chunkit@hku.hk

chunkit

Chan

Chun Kit

Type 1

Completed

Builder & SC

Email Address

poonwa@ha.org.hk

Portal User ID

poonwa01

Last Name

First Name

Poon

Type

Type 2

Training Status

Not completed

Study Role

Builder & SC

Email Addres

chunkit@hku.hk

Portal User ID

chunkit

Last Name

Chan

First Name

Chun Kit

Type

Type 1

Training Status

Completed

Study Role

Builder & SC

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Email Address*

Portal User ID *

Last Name

First Name

Type

Training Status

Study Role

poonwa@ha.org.hk

poonwa01

Poon

Type 2

Not completed

Builder & SC

chunkit@hku.hk

chunkit

Chan

Chun Kit

Type 1

Completed

Builder & SC

Email Address*

poonwa@ha.org.hk

Portal User ID *

poonwa01

Last Name

First Name

Poon

Type

Type 2

Training Status

Not completed

Study Role

Builder & SC

Remove

Email Address*

chunkit@hku.hk

Portal User ID *

chunkit

Last Name

Chan

First Name

Chun Kit

Type

Type 1

Training Status

Completed

Study Role

Builder & SC

Remove

Kindly reminder:
The selected person WILL NOT get access to REDCap Service and REDCap Website until s/he completed the required course(s).

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Other Services (Subject to evaluation and quotation by CTC)

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Withdraw

Back

Service Request

Principal Investigator / PI Delegate

Role

Principal Investigator / PI Delegate

Project Information

Medicinal Product / Clinical Procedure

Organization Information and Contact Person

Agreement / Contract

Document Upload

REDCap Information & Member

REDCap Member

Remarks