1. AMS Training for JCRD Users
By Lydia Liu March 22, 2016

2. Agenda
Training
Testing System

3. Training

4. What is AMS
An HCC pre-approval system
A contract review system

5. In Scope
Janssen (China) Research & Development Center, a Division of Johnson & Johnson (China) Investment Ltd. (JCRD)
Xian Janssen Pharmaceutical Ltd. (XJP)
Company Sponsored Research (CSR) - R&D funded
Clinical Trial Agreement (CTA)
CTA Amendments/Addendums
CRC Agreements signed between Companies and sites (Tri-party Agreement)
Company Sponsored Research (CSR) – XJP Medical Affairs (MAF) funded
Investigator Meeting
CRO Service Agreement - Out-sourced Study
Other CRO Service Agreement (HCC related)
Investigator Initiated Study (IIS) – XJP Medical Affairs (MAF) Funded
Clinical trial agreement (CTA) with research investigator
Clinical trial supplemental agreement

6. Out of Scope
J&J contracting entity is not a J&J China legal entity

7. Clinical Drug Supply Agreements
Request Flow
Clinical Drug Supply Agreements
Site Agreements
Other Agreements
Request submission by applicant
Line Manager Review
C&G Review
Approval Completion
Request submission by applicant
Line Manager Review
Purchasing Manager Review
Approval Completion
Request submission by applicant
Line Manager Review
HCC & C&G / Purchasing Manager & Review
Approval Completion
C&G Ad-hoc HCC *
* Please see notes in the next page

8. Notes of HCC Ad-hoc Review on Site Agreement
HCC will not review individual site clinical trial agreement (CTA)
In stead:
HCC will be involved in the overall study plan review. The study kick-off meeting is a major platform for HCC to conduct overall study plan review. The meeting minutes and the overall plan with budget reviewed by HCC will be uploaded to AMS for HCC’s approval.
After the overall study plan review, C&G will conduct individual CTA review. Anything deviated from pre-approval plan or anything abnormal, C&G will escalate it to HCC for ad-hoc review..
HCC review is primarily focus on:
the justification for research to determine whether it services a duplicative purpose
The justification for the compensation beyond the scope of pre-set fair market value pre-set by C&G and study budget

9. Contract Template
Contract Templates will be centrally controlled by GCO/MAO/C&G/Procurement
AMS will not upload any contract templates

10. How to keep legacy AMS access after new MRC go-live
GCO/MAO employees’ access for Legacy (XJP Portal) will be expired after April 1, 2016.
AMS will have a new portal for GCO/MAO under new MRC.
A group of selected new MRC employees can be granted access to legacy AMS (XJP AMS) for tracking and auditing purpose.
Attached is the list provided by GCO. The List can be updated based at request.

11. Web Site for AMS (JCRD Portal)
Web Site Link:
Log-in information:
User Name: account (邮箱前缀)
Password: Laptop log-in password (开机密码)

12. Next Step Update JCRD employee list as of March 31, 2016
Test the system in real world environment the week of April 4, 2016

13. IT Support
余聪 （Yu Cong) Phone:

14. Testing

15. Testing Information Link: http://10.192.80.173:8021/
User Name: account (邮箱前缀)
Password:

16. Testing Demo

17. Free Testing

18. Thanks