Review this clinical trial agreement and tell me about subject injury provisions.
Issues: Lacks specificity, context, and clear direction. May result in generic information without focused analysis.
Review this clinical trial agreement and identify if the subject injury provisions comply with our institutional standards, particularly regarding sponsor coverage requirements and timeframe for injury claims.
Improvement: Clarifies the specific aspects of subject injury provisions to review and introduces compliance assessment.
You are an experienced clinical trial attorney specializing in pharmaceutical research agreements with expertise in subject injury provisions and compliance assessment against institutional standards.
Review this clinical trial agreement and identify if the subject injury provisions comply with our institutional standards, particularly regarding sponsor coverage requirements and timeframe for injury claims.
Improvement: Assigns a specific expert role to guide the AI's approach and expertise level, improving relevance and depth of analysis.
You are an experienced clinical trial attorney specializing in pharmaceutical research agreements with expertise in subject injury provisions and compliance assessment against institutional standards.
CONTEXT: I'm reviewing this agreement for a Phase II oncology study. My organization has established standard compliance requirements for subject injury provisions that include: 1) sponsor must cover all reasonable and necessary medical costs for trial-related injuries; 2) no requirement for proof of negligence to trigger coverage; 3) coverage must extend at least 2 years post-trial; and 4) subjects must not be required to waive legal rights to seek compensation.
Review this clinical trial agreement and identify if the subject injury provisions comply with our institutional standards, particularly regarding sponsor coverage requirements and timeframe for injury claims.
Improvement: Provides essential background about the trial and clear details on organizational standards for compliance assessment.
You are an experienced clinical trial attorney specializing in pharmaceutical research agreements with expertise in subject injury provisions and compliance assessment against institutional standards.
CONTEXT: I'm reviewing this agreement for a Phase II oncology study. My organization has established standard compliance requirements for subject injury provisions that include: 1) sponsor must cover all reasonable and necessary medical costs for trial-related injuries; 2) no requirement for proof of negligence to trigger coverage; 3) coverage must extend at least 2 years post-trial; and 4) subjects must not be required to waive legal rights to seek compensation.
DOCUMENT:
```
[Clinical Trial Agreement text would appear here]
```
Improvement: Uses delimiters to clearly separate document content from instructions, preventing confusion in processing.
You are an experienced clinical trial attorney specializing in pharmaceutical research agreements with expertise in subject injury provisions and compliance assessment against institutional standards.
CONTEXT: I'm reviewing this agreement for a Phase II oncology study. My organization has established standard compliance requirements for subject injury provisions that include: 1) sponsor must cover all reasonable and necessary medical costs for trial-related injuries; 2) no requirement for proof of negligence to trigger coverage; 3) coverage must extend at least 2 years post-trial; and 4) subjects must not be required to waive legal rights to seek compensation.
DOCUMENT:
```
[Clinical Trial Agreement text would appear here]
```
OUTPUT FORMAT:
- Begin with a 3-4 sentence executive summary of compliance status
- Present detailed analysis in a table with columns for Institutional Standard, Compliance Status (Compliant/Partially Compliant/Non-Compliant), Relevant Contract Language, and Suggested Modifications
- Conclude with clear recommendations for negotiation priorities and specific alternative language
Improvement: Specifies exactly how the analysis should be structured and presented, ensuring consistent and useful output format.
You are an experienced clinical trial attorney specializing in pharmaceutical research agreements with expertise in subject injury provisions and compliance assessment against institutional standards.
CONTEXT: I'm reviewing this agreement for a Phase II oncology study. My organization has established standard compliance requirements for subject injury provisions that include: 1) sponsor must cover all reasonable and necessary medical costs for trial-related injuries; 2) no requirement for proof of negligence to trigger coverage; 3) coverage must extend at least 2 years post-trial; and 4) subjects must not be required to waive legal rights to seek compensation.
DOCUMENT:
```
[Clinical Trial Agreement text would appear here]
```
OUTPUT FORMAT:
- Begin with a 3-4 sentence executive summary of compliance status
- Present detailed analysis in a table with columns for Institutional Standard, Compliance Status (Compliant/Partially Compliant/Non-Compliant), Relevant Contract Language, and Suggested Modifications
- Conclude with clear recommendations for negotiation priorities and specific alternative language
EXAMPLE:
Here's how I'd like you to analyze publication rights provisions:
Institutional Standard: "Institution must retain right to publish results within 12 months of study completion"
Compliance Status: Partially Compliant
Relevant Contract Language: "Institution may publish findings 18 months after final data collection, subject to sponsor's 60-day review period"
Suggested Modification: "Revise to: 'Institution may publish findings no later than 12 months after final data collection, subject to sponsor's 30-day review period limited to protecting confidential information and patent rights'"
Improvement: Provides a concrete example from a different area (publication rights) to demonstrate desired analysis format.
You are an experienced clinical trial attorney specializing in pharmaceutical research agreements with expertise in subject injury provisions and compliance assessment against institutional standards.
CONTEXT: I'm reviewing this agreement for a Phase II oncology study. My organization has established standard compliance requirements for subject injury provisions that include: 1) sponsor must cover all reasonable and necessary medical costs for trial-related injuries; 2) no requirement for proof of negligence to trigger coverage; 3) coverage must extend at least 2 years post-trial; and 4) subjects must not be required to waive legal rights to seek compensation.
TASK: Review the subject injury provisions and:
1. Assess compliance with each of our four institutional standards listed above
2. Identify any gaps between the agreement language and our requirements
3. Analyze whether exceptions or qualifications in the language create compliance issues
4. Suggest specific modification language to bring non-compliant provisions into compliance
DOCUMENT:
```
[Clinical Trial Agreement text would appear here]
```
OUTPUT FORMAT:
- Begin with a 3-4 sentence executive summary of compliance status
- Present detailed analysis in a table with columns for Institutional Standard, Compliance Status (Compliant/Partially Compliant/Non-Compliant), Relevant Contract Language, and Suggested Modifications
- Conclude with clear recommendations for negotiation priorities and specific alternative language
EXAMPLE:
Here's how I'd like you to analyze publication rights provisions:
Institutional Standard: "Institution must retain right to publish results within 12 months of study completion"
Compliance Status: Partially Compliant
Relevant Contract Language: "Institution may publish findings 18 months after final data collection, subject to sponsor's 60-day review period"
Suggested Modification: "Revise to: 'Institution may publish findings no later than 12 months after final data collection, subject to sponsor's 30-day review period limited to protecting confidential information and patent rights'"
Improvement: Breaks down the complex review into specific sequential steps, ensuring a comprehensive and methodical analysis.
COMPLETE OPTIMIZED PROMPT:
You are an experienced clinical trial attorney specializing in pharmaceutical research agreements with expertise in subject injury provisions and compliance assessment against institutional standards.
CONTEXT: I'm reviewing this agreement for a Phase II oncology study. My organization has established standard compliance requirements for subject injury provisions that include: 1) sponsor must cover all reasonable and necessary medical costs for trial-related injuries; 2) no requirement for proof of negligence to trigger coverage; 3) coverage must extend at least 2 years post-trial; and 4) subjects must not be required to waive legal rights to seek compensation.
TASK: Review the subject injury provisions and:
1. Assess compliance with each of our four institutional standards listed above
2. Identify any gaps between the agreement language and our requirements
3. Analyze whether exceptions or qualifications in the language create compliance issues
4. Suggest specific modification language to bring non-compliant provisions into compliance
DOCUMENT:
```
10.1 Subject Injury. Sponsor shall only cover costs for injuries directly resulting from properly administered study drug, excluding injuries from standard of care procedures. Sponsor's obligation to cover such costs is not contingent upon proof of negligence by any party. Sponsor's obligation to cover subject injuries shall extend for one (1) year following completion of subject's participation. Nothing in this Agreement shall be construed to limit a Subject's legal rights to seek compensation for injuries through any legal means.
```
OUTPUT FORMAT:
- Begin with a 3-4 sentence executive summary of compliance status
- Present detailed analysis in a table with columns for Institutional Standard, Compliance Status (Compliant/Partially Compliant/Non-Compliant), Relevant Contract Language, and Suggested Modifications
- Conclude with clear recommendations for negotiation priorities and specific alternative language
EXAMPLE:
Here's how I'd like you to analyze publication rights provisions:
Institutional Standard: "Institution must retain right to publish results within 12 months of study completion"
Compliance Status: Partially Compliant
Relevant Contract Language: "Institution may publish findings 18 months after final data collection, subject to sponsor's 60-day review period"
Suggested Modification: "Revise to: 'Institution may publish findings no later than 12 months after final data collection, subject to sponsor's 30-day review period limited to protecting confidential information and patent rights'"
AI GENERATED RESPONSE:
EXECUTIVE SUMMARY
The subject injury provisions in the Clinical Trial Agreement are
Non-Compliant with our institutional standards in two critical areas. While the agreement properly addresses non-negligence coverage and avoids subject waivers of legal rights, it fails to meet our requirements for sponsor coverage of all trial-related injuries and extends coverage for only 1 year instead of the required 2 years post-trial. These deficiencies create significant liability exposure for our institution and require immediate negotiation.
DETAILED ANALYSIS
| Institutional Standard |
Compliance Status |
Relevant Contract Language |
Suggested Modifications |
| Sponsor must cover all reasonable and necessary medical costs for trial-related injuries |
Non-Compliant |
"Sponsor shall only cover costs for injuries directly resulting from properly administered study drug, excluding injuries from standard of care procedures." |
Replace with: "Sponsor shall cover all reasonable and necessary medical costs for any injury related to participation in the trial, including those from study procedures, study drug administration, or any trial-related activity." |
| No requirement for proof of negligence to trigger coverage |
Compliant |
"Sponsor's obligation to cover such costs is not contingent upon proof of negligence by any party." |
No changes needed |
| Coverage must extend at least 2 years post-trial |
Non-Compliant |
"Sponsor's obligation to cover subject injuries shall extend for one (1) year following completion of subject's participation." |
Replace with: "Sponsor's obligation to cover subject injuries shall extend for a minimum of two (2) years following completion of subject's participation in the trial." |
| Subjects must not be required to waive legal rights to seek compensation |
Compliant |
"Nothing in this Agreement shall be construed to limit a Subject's legal rights to seek compensation for injuries through any legal means." |
No changes needed |
NEGOTIATION PRIORITIES
1.
HIGH PRIORITY: Expand the scope of covered injuries to include all trial-related injuries, not just those from study drug
2.
HIGH PRIORITY: Extend coverage period from 1 year to minimum 2 years post-trial participation
3.
MEDIUM PRIORITY: Add explicit language confirming sponsor's primary financial responsibility before institution insurance
Final Result: The optimized prompt delivers a comprehensive, structured analysis with clear compliance assessment and specific recommended language changes. The output is directly actionable for the legal team.
