| Course | HCR 575 Management and Negotiation of Clinical Trial Budgets and Contracts |
|---|---|
| Module | Module 6 |
| Paper type | Contract redline memo |
| Length | About 658 words, 5 pages |
| Format | APA 7 student paper |
| School | Arizona State University |
| Program | MS in Clinical Research Management |
| Updated | October 2026 |
Free sample paper for HCR 575 Module 6
Redline Memo: Proposed Edits to the Sponsor's Draft Clinical Trial Agreement for LUNG-302
Student Name
MS in Clinical Research Management, Arizona State University
HCR 575: Management and Negotiation of Clinical Trial Budgets and Contracts
Instructor Name
Month Day, Year
Redline Memo: Proposed Edits to the Sponsor's Draft Clinical Trial Agreement for LUNG-302
Memo
To: Office of Research Contracts. From: Contracts Specialist, Oncology Research. Date: October 10, 2026. Re: Sponsor draft clinical trial agreement, Protocol LUNG-302.
The sponsor's draft follows its standard template and protects the sponsor well, but several clauses would expose the institution to risk or restrict rights that our policies require us to keep. My recommended edits are below, ranked by priority. The aim is a fair agreement the sponsor can accept quickly, so I note where we can concede.
Proposed Edits
| Clause | Sponsor's draft | Proposed edit | Reason | Priority |
|---|---|---|---|---|
| Indemnification | Sponsor indemnifies only for claims arising from the study drug's manufacture | Sponsor indemnifies for claims arising from the study drug and protocol-required procedures, except those caused by the site's negligence or deviation from the protocol | The site follows the sponsor's protocol and should not bear liability for its required procedures | Must have |
| Subject injury | Sponsor pays for injury treatment "not covered by insurance" | Sponsor pays reasonable costs of diagnosing and treating injuries caused by the study drug or protocol procedures, without first billing the participant's insurance | Participants should not bear costs or coverage denials for research injuries; the consent form must match this clause | Must have |
| Publication | Sponsor approval required before any publication | Site may publish results after a 60-day sponsor review for confidential information and patent filing, with an additional 60-day delay on request for patents | Academic freedom; institutional policy prohibits sponsor approval rights | Must have |
| Confidentiality | Indefinite obligation covering all study information | Five-year term after study end; excludes information already public, independently developed or required to be disclosed by law | Indefinite terms are unworkable; required disclosures to regulators and IRBs must be allowed | Should have |
| Data and intellectual property | Sponsor owns all data and inventions | Sponsor owns study data and inventions arising from the study drug; site keeps medical records and inventions made independently of the protocol, with a right to use study data for internal research and education | Separates the sponsor's legitimate interest from the institution's own work | Should have |
| Record retention | Site retains records for 25 years at its own cost | Site retains records as required by regulation; longer retention at sponsor's cost with storage fees | Federal rules set the minimum (21 C.F.R. § 312.62(c)); the sponsor should pay for longer storage | Should have |
| Payment | Payment within 90 days of invoice; screen failures not paid | Payment within 45 days; screen failures paid at the screening visit rate up to a 1:3 ratio; start-up fee nonrefundable | Cash flow and recovery of screening effort | Should have |
| Termination | Sponsor may terminate at will; site paid only for completed visits | Sponsor may terminate with 30 days' notice; site paid for completed work, noncancellable obligations and close-out costs | Close-out work continues after termination | Can concede notice period |
Clauses Acceptable as Drafted
The insurance clause, the compliance-with-laws clause, the financial disclosure clause requiring investigators to report financial interests (21 C.F.R. §§ 54.1-54.6) and the governing-law clause are acceptable, though governing law would ideally be the site's state.
Consistency Checks
The subject injury language must match the informed consent document, which has to describe compensation and treatment available for research injury (45 C.F.R. § 46.116). The payment terms must match the budget built from the coverage analysis. Publication terms must match the investigator's obligations under the protocol.
Negotiation Notes
The three must-have edits concern legal exposure, participants and academic freedom and should be held firmly. The should-have edits are reasonable industry norms the sponsor is likely to accept, perhaps with small changes such as a seven-year confidentiality term. Termination notice and governing law are points to trade if the sponsor resists on others (Pfeiffer & Windscheigl, 2021).
Conclusion
With eight edits, the agreement would protect participants from research injury costs, the institution from liability for the sponsor's protocol and the investigators' right to publish, while giving the sponsor the confidentiality, data ownership and patent protection it legitimately needs.
References
Financial disclosure by clinical investigators, 21 C.F.R. §§ 54.1-54.6 (2025).
General requirements for informed consent, 45 C.F.R. § 46.116 (2025).
Pfeiffer, J., & Windscheigl, M. (2021). Managing clinical trials: Budgets and contracts (2nd ed.). LAD Publishers.
Recordkeeping and record retention, 21 C.F.R. § 312.62 (2025).
Reading the HCR 575 Module 6 assignment instructions
Assignment 4 in HCR 575, worth 100 points, falls in Week 6, which covers ownership and recordkeeping, data, intellectual property and publications, termination and miscellaneous contract matters. The task is to edit a clinical trial agreement: read a sponsor's draft, identify clauses that create risk for the site or conflict with institutional policy and propose revisions with reasons. Your instructor supplies the draft in Canvas. The clauses that matter most at most sites are indemnification, subject injury, publication rights, confidentiality, data and intellectual property, record retention, payment and termination. Present your edits so a contracts office could act on them: the original language, the proposed change and why, and an indication of which points are essential. Check that the agreement agrees with the consent form and the budget, since inconsistencies among the three documents are a common source of problems later.
How the HCR 575 Module 6 example is put together
The sample is a memo to the research contracts office. A short opening states the goal: a fair agreement the sponsor can accept quickly. The core is a table of eight clauses with the sponsor's draft, the proposed edit, the reason and a priority ranking. A short section lists clauses acceptable as drafted, and another checks consistency with the consent form, budget and protocol, citing the federal rules involved. Negotiation notes explain which edits to hold and which to trade, and the conclusion summarizes what the edits protect for each party. Proposed language is short enough to paste into the agreement, which is how contracts offices work.
Where the marks sit in the HCR 575 Module 6 rubric
Canvas scores the contract edits out of 100. Readers reward a review that identifies the clauses that matter, proposes specific revised language rather than general objections, explains each edit with reference to risk, regulation or institutional policy, recognizes the sponsor's legitimate interests and prioritizes edits for negotiation. Points are lost when the review misses major clauses such as subject injury or publication, when edits are vague, when the reasoning ignores regulations such as record retention and when every point is treated as non-negotiable. Readers value consistency checks across the agreement, consent form and budget, since mismatches are a frequent finding in audits. Edits written as usable clause language, rather than comments, usually score higher.
HCR 575 Module 6 help from the desk
Read the whole agreement before editing any clause. Focus on indemnification, subject injury, publication, confidentiality, data, record retention, payment and termination. Write the proposed language, not just the problem. Give a reason for each edit. Rank edits so you know what to hold and what to trade. Check the consent form and budget against the agreement. If a clause's legal effect is unclear, the desk can help you think through what it would mean in practice. Keep a copy of the sponsor's original draft beside your edits so reviewers can compare them line by line. Note which edits you expect the sponsor to accept easily and which will need discussion, since that ranking guides the negotiation in the following week.
Write yours, or have the desk draft it
This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.
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HCR 575 Module 6 questions, answered
Where can I find a free HCR 575 Module 6 sample paper?
Scroll up for the full redline memo responding to a sponsor's draft agreement, the Assignment 4 sample.
Which clinical trial agreement clauses matter most to sites?
Indemnification, subject injury, publication rights, confidentiality, data and intellectual property, record retention, payment and termination.
Should a sponsor be able to approve publications?
Sites generally allow sponsor review for confidential information and patents but not approval of whether results are published.
Why must the subject injury clause match the consent form?
The consent form tells participants what compensation and treatment are available, so the contract must deliver the same promise.
How long must clinical investigators keep study records?
At least two years after approval of the marketing application or after the investigation ends, under 21 C.F.R. § 312.62(c).