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

Agenda Training Testing System

Training

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

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

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

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

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

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

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.

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

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

IT Support 余聪 （Yu Cong) Phone: 010 58218507 Email: CYU6@ITS.JNJ.COM

Testing

Testing Information Link: http://10.192.80.173:8021/ User Name: email account (邮箱前缀) Password: 123456

Testing Demo

Free Testing

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