Study Protocol Identification Full Title definition

Study Protocol Identification Full Title. Version Number: Date: / / List of Key attachments: : Special Conditions Please Paste/Enter Text Below Protocol Number: Site:

Study Protocol Identification Full Title. Version Number: Date: / / List of Key attachments: : Special Conditions Please Paste/Enter Text Below The definition of “Relevant Privacy Laws” in Clause 1.1 is amended by replacing the word “and” after the words “Privacy Xxx 0000 (Cth)” with the word “or”. Clause 2.1 is amended to: replace the words “… the Protocol and any conditions of the Reviewing HREC. In addition the Parties must comply with the following, as applicable:” with the words “the following, in the following order of precedence” replace the following words: “the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidance governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials; any Study specific and standard operating procedures provided by the CRG prior to the commencement of the Study; and any reasonable direction given by the CRG in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements.” with the words: “ any condition of the Reviewing HREC; and the Protocol; and additionally as applicable: the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidance governing the conduct of clinical research in the jurisdiction of the Study.” the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials; any Study specific and standard operating procedures provided by the CRG prior to the commencement of the Study; and any reasonable direction given by the CRG in order to ensure the safe conduct of the tria...

Study Protocol Identification Full Title. Version Number: Date: / / List of Key attachments: : Special Conditions Item Relevant Clause of the Agreement Proposed Special Condition/ Amendment Protocol Number: Site:

Examples of Study Protocol Identification Full Title in a sentence

• Copy available online at: xxxx://xxxxxxxxxxxxxxxxxx.xxx.xx/xxxxxx-xxxxxxxxxxx/xxxxxxxx-xxxxxx/xxxxxxxx-xxx-xxxxxxxxxxxx-xxxxxxxxxx/ Study Protocol Identification Full Title: Version Number: Date: / / List of Key attachments: Special Conditions The parties agree to amend the terms of this Agreement as follows.

• So, if somebody says I want to find out where this policeman lives, the District Manager would say no, I’m not going to do that because it’s exempt.

• A director is to be taken to be present at a meeting of directors if the director is present in person or by alternate director, or participates in the meeting by telephone, or by any contemporaneous means of audio or audio visual communication, or any other form of technology or electronic means approved by the directors.

• Matters to be reimbursed Internet connectivity Schedule 3 Study Protocol Identification Full Title: Version Number: List of Key Attachments: Schedule 4 Special Conditions Ref: Relevant Clause of the Agreement Amendment Introduction The introduction is deleted and replaced with ‘’This agreement is made between the Sponsor, the Principal Investigator and the Institution’’.

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Study Protocol Identification Full Title. Version Number: Date: / / List of Key attachments: : Special Conditions Amendment to definition of Confidential Information The parties agree that the definition of Confidential Information in Clause 1.1 is amended by deleting the entirety of the final line of that definition and instead inserting the following at the end of the definition: “Confidential Information does not include: Personal Information; and the terms of this Agreement.” Amendment to clause 4.5 The parties agree that clause 4.5 is amended by inserting the following after the word “value” at the end of the clause: “it does not include the payment or reimbursement of any salary, wage, entitlement or expense in the usual and proper course of employment.” Amendments to clause 9 The parties agree that clause 9 is further amended by inserting the following clauses 9.7 and 9.8:

Study Protocol Identification Full Title. Version Number: Date: / / List of Key attachments: : Special Conditions Ref: Relevant Clause of the Agreement Amendment Introduction The introduction is deleted and replaced with ‘’This agreement is made between the CRG, the Institution and the Principal Investigator’’. Purpose of the Agreement Delete section B of the “Purpose of the Agreement” and replace with the following: “The Institution and the Principal Investigator are responsible for the conduct of the Study at the Study Site(s).”