Source: http://clinicaldevice.typepad.com/cdg_whitepapers/clinical-sponsors/
Timestamp: 2017-10-21 01:19:43
Document Index: 287186982

Matched Legal Cases: ['art 312', 'art 812', 'art 812', 'art 812', 'art 11', 'art 50', 'art 54', 'art 56', 'art 99', 'art 809', 'art 820', 'art 312', 'art 812', 'art 812']

CDG Whitepapers: Clinical sponsors
Posted at 01:19 PM in Clinial Investigations, Clinical Evaluation Reports, Clinical Investigation Plan, Clinical Investigations, Clinical Research Quality Management System, Clinical sponsors, Clinical Trial Procedures, Clinical Trials, Protocols, Registry Studies | Permalink | Comments (0)
The 2014 Clinical Research Associate Handbook Is Here!
The 2014 (Paper) CRA Handbook Is Here!
A Medical Device Handbook for Regulatory and Clinical Research Professionals
A Promotional Piece by Nancy J Stark, PhD.
The CRA Handbook was the first "book" I ever edited. I was jealous because, at the clinical and regulatory conferences I attended, little books of Part 312 for pharmaceutical clinical investigations were handed out for free by the vendors. But there was nothing available for the poor Cinderella of medical devices. To balance the scales, I wrote my own handbook for device clinical and regulatory professionals and added some extra reference materials to make it even more useful.
Devices Are Different from Drugs
If you work in the medical device world, you know that good clinical practices for devices are vastly different from pharmaceuticals in implementation.
Size and Storage of Investigational Products
The first big difference is with size and storage. Once I had a device the size of a breadbox. The IRB insisted the pharmacy keep the investigational breadbox-sized devices under double-lock and key, as was their practice with investigational drugs. But pharmacies don't have storage room for 100 breadboxes, and pharmacies don't dispense medical devices. The investigator had storage room, but no double-locked box for large devices. After weeks of negotiation--and costly delays to the investigation--the IRB agreed to allow the investigator to store the large devices in her office with a single lock on the door. The unique storage requirements of devices is unfamiliar to drug folks.
CRA Handbook 2014
I use the CRA Handbook as a desk reference for US regulations, a list of guidances, and regulatory and clinical requirements. When I traveled, I used it as a reference tool during meetings and for late-night hotel work. By the end of the year, my copy was dog-eared, filled with annotations, and colorful with Post-It tags. All my favorite paragraphs were marked. To learn more, go here.
The second big difference is that there are two levels of approval for study initiation in devices. In the US, device clinical investigations may be conducted under the abbreviated IDEs or under full IDEs (Investigational Device Exemptions). Abbreviated IDE studies make up 80-90% of the clinical investigations in the States, do not require FDA approval for initiation, and do not require a final report to FDA. There is no registry or list of abbreviated IDE studies. I'm getting my numbers from private interviews; for example, manufacturers of dermal contact products might do 100 clinical investigations a year on healthy, volunteer employees. While full IDE studies get all the attention, so-called 'non-IDE' studies are confusing to drug folks.
The third big difference between device and pharmaceutical investigations is with reporting of adverse effects and events. Adverse effects are device related, adverse events are not. Unless otherwise specified by the protocol, only USADEs (unanticipated, serious, adverse device effects) are reported to FDA. Not reporting anticipated adverse effects to FDA is befuddling to drug folks.
Two major things changed in the regulatory world since 2011 and are reflected in the 2014 edition of the Handbook. The Declaration of Helsinki was updated to reflect the changes made in by the World Health Association in 2013, and 21 CFR Part 812.119 on investigator disqualification was expanded and strengthened. What's missing?
Should we add other documents to the Handbook to make it more useful to you? Tell us what to add.
01 CFR Part 812-Investigational Device Exemptions
02 CFR Part 812.20-Premarket Approval Applications
03 CFR Part 11-Electronic Records: Electronic Signatures
04 CFR Part 50-Protection of Human Subjects
05 CFR Part 54-Financial Disclosure
06 CFR Part 56-Institutional Review Boards
07 CFR Part 99-Dissemination of Information
08 CFR Part 809-In Vitro Diagnostic Products
09 CFR Part 820.30-Quality System--Design Controls
10 Expedited Review List
11 Risk Based Monitoring--The New FDA Guidance
12 Declaration of Helsinki (2013)
14 ISO 14155 (2011) Summary
15 Adverse Events and Effects
16 FDA Guidances
The electronic version of the handbook is in the works.
Julie is editing as fast as she can to get the electronic copy updated, functional, with working links and pretty colors. She expects it to be completed by June 2014. If you would like to be notified when it is ready, contact Peggy and have your name added to a notice list.
If the link doesn't work in your system, email us at cdginc@clinicaldevice.com or visit our website at www.clinicaldevice.com
Posted at 04:50 PM in Clinical Investigation Plan, Clinical Investigations, Clinical Research Quality Management System, Clinical sponsors, Clinical Trial Procedures, Clinical Trials, CRO, FDA, Monitoring, risk-based monitoring | Permalink | Comments (0) | TrackBack (0)
Choosing A Device CRO-Consultancy
©2012 Clinical Device Group Inc, all rights reserved.
Device contract research organizations (CROs) play a different role in the product development cycle than drug CROs, and it is unrealistic to expect a drug CRO to deliver the service a medical device sponsor needs. In the drug world a CRO is used more like a Kinko's or a dry cleaners: the sponsor drops off the protocol on Monday and picks up the report on Friday. The CRO acts independently and is legally responsible for the sponsor obligations identified in the contract. [1. 21 CFR Part 312.52]
In the device world there is no possibility to legally transfer sponsor obligations to a CRO. The manufacturer may use the services of a CRO, but legal responsibility for sponsor obligations remain with the manufacturer. As a result, medical device CRO must serve as a consultancy; collaborating intimately with the manufacturer on sponsor responsibilities such as recording and reporting adverse device effects, investigator noncompliances, device deficiencies, investigator and study staff training to proper device use, and so forth. The device CRO-consultancy cannot act independently because the legal responsibility of their actions remain with the manufacturer.
As the manufacturer you should choose a CRO-consultancy that complements your corporate personality, fills the knowledge gaps in your organization, and makes themselves readily available to you. Here are some specific characteristics that you can evaluate.
Device experience of top management
Does the CEO have medical device experience? The career history and experience of top management sets the focus of any company. When you are interviewing a CRO, be sure to ask for the CVs of top management. Have they worked for medical device firms? Have they worked in clinical research or regulatory roles? Are they sensitive to the differences in regulations between devices and pharmaceuticals? Without device experience at the top, you are unlikely to get device experience at the level of implementation.
CDG Inc—A Device CRO Here to Stay
CDG is a small, networked CRO offering services in biological safety, quality design, clinical research, statistics, audits, reimbursement, and clinical evaluations for medical devices. We have many clients who use us as a consultancy—they call for advice when they want direction about how to proceed.
We have been in business since 1990, and our President has been in the device industry since before Part 812 was final! Please call us to discuss consulting needs for your firm. Click here for more information or call 773-489-5706.
How big is the CRO in terms of number of employees or annual gross revenue? Little sponsors get swallowed-up by big CROs. If your project is small compared to the other projects the CRO is running you will be ignored when bigger clients have problems and demand attention. The disparity in size leaves you with no power to demand immediate help. Small CROs will value your business and are more likely to make themselves available to advise you.
But in fairness, if you are a large device manufacturer you may be more comfortable working with a large CRO. Large CROs can bring more sophisticated electronic data tools, financial reporting tools, or other management advantages that small CROs cannot afford.
Progressive slices of the pie—estimates and schedules
In CDG's experience, device projects tend to be progressive slices of the greater pie. For example, the first project might be to review device biological safety, if that goes well we may be asked to review a protocol, and then to calculate an array of possible sample sizes, then to implement a study, and so forth. One project may turn into five projects or twenty-five project over time.
In any case, once you settle on some specifications the CRO should be able to give you an estimate and schedule. I am using the word "estimate" to mean the number of labor-hours it will take to complete the project and the word "schedule" to mean the overall duration of the project. For example, it might require 40 man-hours to write a clinical evaluation over a duration of ten weeks.
If the estimate and schedule are within 25% of the final cost and duration, the manufacturer has done a good job of planning and the CRO has done a good job of execution. But I promise you, there is no way the project will go to completion without a change in specifications.
It is key for the device manufacturer to ask, "Who will do the work?" Some large CROs have been known to show the CVs of device-experienced personnel during the negotiation phase, but then have another—device-inexperienced—individual actually do the work. It is understandable that personnel availability may change from the time a proposal is first discussed to the time the contract is finalized, but it is wrong to assign new individuals who don't have the necessary expertise.
During project negotiations be sure to ask the CRO if they have the expertise to do the work. And then don't hesitate to object later if the assigned individual isn't as skilled, thorough, or knowledgable as you need them to be. From time-to-time every company makes personnel adjustments and it should not become a big issue.
Poll Question: How did you use a CRO last year, if at all?
How did you use a CRO last year, if at all? Respond to the poll question and help us learn about our industry. Your answers are completely confidential and will be used only for my own research. The average responses will be posted in an upcoming whitepaper. Answer me here. —Nancy
Independent experts: one-person firms
Many of the finest medical device consultancies are independent, one-person firms. They have chosen an entrepreneurial lifestyle, preferring the independence of self-employment to the security of a routine paycheck. It is reasonable to ask what experience they have in the device industry, why they chose to work for themselves, and if they can commit to the duration of your project.
I've had some interesting bosses over the years. When I decided to become a consultant in 1990, my soon-to-be-ex boss told me that "consultant" was a code word for "I'm unemployed." I took that as a challenge and knew that I would have to work at building a business persona. It was important that manufacturers perceived Clinical Device Group Inc as a company that was here to stay.
When out-sourcing to a new independent expert, look for signs of someone trying to create a business: do they have a business name, business cards, a marketing effort, a website, a brochure, conference booths, speaking engagements, and the like? Look for people who have actually worked in the device industry and understand how devices are conceived, designed, tested, investigated, and commercialized. Independent experts run businesses themselves and will bring a sensitivity to the business needs of your organization.
Many independent experts form relationships with other independents and work together to provide services to clients beyond their own specific expertise. Ask what services they can provide to you directly via employee or sub-contractor, and whom they can refer to you. They can often provide you with a full range of clinical and regulatory services just like any other full-service CRO through their strategic alliances.
If the experts are in a network, who is the project leader on their side? How will communications flow, knowing that the experts may live in different states? Will you have direct access to the project implementers? Think of the management model used in most organizations; the doer in clinical research is free to send an email to the doer in regulatory affairs, but the managers of both functions are copied to keep them in the loop.
Who will bill whom? I follow a general contractor model: my sub-contractors bill CDG, CDG in turn bills the manufacturer.
Do you need (or want) separate non-disclosure agreements (NDAs) from each sub-contractor? Occasionally manufacturers want NDAs from each sub-contractor, but more commonly the primary NDA requires CDG to have NDAs with each sub-contractor so that the requirement for confidentiality flows through.
I have had an independent expert walk away from a contract in the middle of a project in order to take a job. I respect everyone's need for security, but it is dishonest for experts to present themselves as consultants who are here to stay, and then betray that promise.
Businesses who are committed to their industries show it by finding affordable ways to demonstrate that commitment. CROs or consultant may offer public presentations, contribute written articles, participate in standards development, or find other ways to give back to the industry and to mentor younger persons. Looking at the CRO's commitment to the industry is one way to judge their staying power.
"Standing" refers to the reputation of the CRO or consultant in the eyes of clients and peers. For older CROs or independents standing may be self-evident; for younger CROs or independents you may want to ask for references.
I have had the unusual situation of a client asking me if I agreed with the opinion of another consultant. I did not, and cited the regulations on which I based my opinion. For the manufacturer it was a question of whom to believe. It is useful if you have confidence in the advice the CRO is giving you.
Project Management for Clinical Studies
Stark NJ,Project Management for Clinical Studies, Clinical Device Group Inc, Chicago, IL (2003).
A bidding process is a process where the submits a bid for a job or project. The process requires strict specifications for the project (i.e. the sponsor must know exactly what they want) and works well for "cookie-cutter" investigations. The idea is that bids are obtained from several potential suppliers and the "best" bid is accepted, where "best" is some combination of people, resources, and cost.
It's a personal choice on the part of CROs, but I rarely participate in bidding situations. I have put many hours of original research and considerable proprietary business practice in a bid, only to have the project go to another party and my proprietary information used as a learning tool for the cheaper firm. In one case the sponsor decided not to out-source at all, but to do the clinical trial in-house based on what they learned from the bids they solicited.
If you use a bidding process, it's important to play fair and ethically. Sponsors and manufacturers get reputations among CROs, too; and you don't want to risk being in a situation where no-one of quality will contract with you.
Capabilities meeting
Larger CROs will often travel to the manufacturer's site and make a capabilities presentation. Smaller CROs will often host a capabilities meeting, but the cost of travel is the burden of the manufacturer. Most frequently the meeting takes place by teleconference. No matter how it is arranged, the CRO should be able to make a presentation reviewing their company history, business model, service capabilities, technology capabilities, and resources.
If I travel to a conference I may learn, say, four new things. If it cost me $2000 in travel expenses to attend, then a new piece of information costs me $500. As a CRO, I have an unspoken rule of thumb. I will give away two new pieces of information to a potential client to establish credibility, but no more.
As the manufacturer, you are engaging the CRO in conversation so as to assess their knowledge, confidence, organization, and corporate personality. You should expect to learn a couple of new things during the meeting.
Website, brochure, company information, references
There are many ways for a CRO to present their capabilities with professional, take-home, printed materials. Whether it is a simple file folder, a four-color glossy, or an electronic brochure, you are looking for a material that describes the CRO's organization, presents its vision and mission, describes it scope of services, and tells you who they are.
[1] 21 CFR Part 812.32 Transfer of obligations to a contract research organization.
Posted at 10:52 AM in Clinical sponsors, Clinical Trials, Consultant, CRO | Permalink | Comments (2)
Clinical trial agreements (CTAs) are the legally binding agreements between a sponsor and an institution (site) as to how certain business and property rights will be dealt with between the parties. These agreements are separate from Investigator Agreements and Confidentiality Agreements and are not regulated by FDA or disclosable to FDA. CTAs are important because they allocate risk, responsibility, financial support, and obligations of the parties; and they protect the rights of the parties.
Usually the sponsor presents an initial draft of the agreement to the institution, and then each of the terms and conditions are negotiated by the party's attorneys. Agreements follow a typical format of: preamble, acknowledgements and responsibilities, term and termination, payment and reimbursement of costs, HIPAA and patient privacy, publication, data ownership and use, intellectual property, indemnification and insurance, subject injury, best efforts, waiver of consequential damages, miscellaneous (export controls, governing law, and dispute resolution/arbitration/mediatio, exhibits), and signatories. (1. Perry-Northwestern University)
The most common problem areas are publication, data ownership and use, intellectual property, indemnification and insurance, subject injury, best efforts, and signatories. In the text below I explore these problems and solutions suggested through various model CTA templates. (2. Weill Medical College of Cornell.) (3. UIDP) (4. MAGI) (5. Arizona template) (6. IOM template)
Universities, teaching hospitals, and other not-for-profit institutions are grounded in the principles of academic freedom and the discovery and sharing of information. Furthermore, in order to maintain a tax-exempt status, they must fulfill certain duties such as education of students, creating generalizable knowledge, or dissemination of knowledge. (7. Guiding Principles)
Sponsors, manufacturers, and other for-profit firms have commitments grounded in creating value for their shareholders, providing useful goods and services, and expanding the state of the art. They contribute to society by developing and providing new technologies to ease the medical conditions of mankind, but they must be profitable to survive.
Since neither party can live without the other, the challenge is to find contractual language that supports the mission of each within the constraints that limit them.
[F] Publication
The publication clause outlines who can publish what, and when. The clause is important to industry because they need to hold early developmental information confidential until the design of the device has matured into a functional, manufacturable, and marketable configuration. Revealing information too early, or revealing the wrong information, may allow your competitors to learn from your mistakes. Sponsors are also concerned about the accuracy of reporting, both of data and of product descriptions. And for multi-center studies, solutions are needed that allow for a complete manuscript incorporating results from all sites, and which pre-determines the order of authors.
Conversely, a non-profit institution needs to publish new knowledge. Publication creates recognition of the investigator's efforts, allows results to be used in future trials, enhances the site's prominence, contributes to public knowledge, and allows graduate students to use the data for their theses.
A typical industry draft clause might say, in essence, "Institution shall submit to Sponsor a copy of any proposed publication at least 90 days prior to submission for review and approval."
Compromise language suggested by the University of Arizona is, "Sponsor has no objection to publication by Institution of the results of the Study based on information collected or generated by Institution, whether or not the results are favorable to Sponsor. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor the opportunity to review any proposed publication or other type of disclosure at least thirty (30) days before it is submitted for publication or otherwise disclosed. If any patent action is required to protect Inventions, Institution agrees to delay the disclosure for a period not to exceed ninety (90) days from the date Institution initially submitted the proposed publication, or other type of disclosure, to Sponsor for review. Institution will, on request, remove any Confidential Information before disclosure.
If Study is part of a multi-center study, Institution agrees that the first publication is to be a joint publication covering all centers. However, if a joint manuscript has not been submitted for publication within twelve (12) months of completion or termination of Study at all participating sites, Institution is free to publish its results separately…." (5. Arizona template)
[G] Data ownership and use
Data ownership and use is another common sticking point. Sponsors may argue that they "own" the data because they have paid for it, but Institutions counter that they cannot retain their non-profit status if they engage in contract research or "work-for-hire". Institutions want to protect the right to use study data for non-commercial, research, development, and educational, purposes.
A typical industry draft clause might read, "All study data shall be the sole and exclusive property of Sponsor."
MAGI offers this compromise clause, "Site owns all Source Documents. Sponsor owns all Sponsor Data. Site owns all Specimens and Genetic Data, and grants Sponsor access to such property only for purposes of the Study. Sponsor and Site may freely use their own data subject to Subject consent and IRB approval. In addition, Site may freely use Sponsor Data after first multicenter Publication is published or Sponsor waives right to a multicenter Publication. Sponsor has no right to Site’s pre-existing biological samples, genomic database, or other proprietary database." Sponsor Data is defined as, "Study lab test results, CRFs and other reports completed by Site or Investigator per the Protocol, Agreement or other written instruction by Sponsor, excluding Source Documents and Genetic Data. Specifically excludes results derived from analysis of data." (4. MAGI)
ISO 14155 "Clinical investigation of medical devices in human subjects—
good clinical practice" (2011)
What makes this ISO 14155 training so special? The author served on the Editing Committee of Working Group 4, the inner circle of individuals who put finger-to-keyboard and wrote the standard. In this three-hour recorded training Dr. Stark discusses the standard in a topic-by-topic format; identifying what is new, what were the controversies, and what was the Working Group's thinking in adopting the language it did. It is this background information that helps you apply the standard appropriately to your study.
You can buy this newly released training on CD on our website cdginc@clinicaldevice.com or by phoning 773-489-5706. Private training from Dr. Stark is also available.
[H] Intellectual property
Intellectual property is a little different than data ownership, in that it covers who has the right to obtain a patent, or own an invention, development, or discovery.
A typical industry draft clause may read, "Any inventions made as a result of Institution's performance of this Agreement will be disclosed promptly to Sponsor and shall be deemed the property of Sponsor." But again, the sale of information is at cross-purposes with the non-profit mission of the institution.
The University of Arizona offers this compromise clause, "Inventorship of any inventions, developments, or discoveries, whether patentable or not (collectively referred to as "Intellectual Property"), resulting from the performance of the Study, shall be allocated according to U.S. Patent law (Title 35 U.S. Code) in effect at the time the Intellectual Property was created…." (5. Arizona template)
[I] Indemnification and insurance
Indemnification is language whereby one party agrees to protect another against an anticipated loss or damage; insurance is a policy through a third-party which guarantees payment to cover the costs of loss or damage. Although FDA does not require sponsors to carry insurance to cover the possibility of loss or damage to the Institution resulting from the study, most Institutions will have insurance requirements for sponsor-initiated clinical trials. In the event a sponsor in unable to meet the insurance requirement, the study will probably undergo a clinical risk assessment via which the institution attempts to assess the likelihood of loss or damage.
A typical industry draft clause might read, "Sponsor shall indemnify and hold harmless Institution from any damages and liability that are caused by Sponsor's negligence."
A compromise clause might read, "Sponsor shall indemnify, defend, and hold harmless Institution from any damages and liability that arise out of the proper administration of the Study device, Study-required procedures, Sponsor's use of the results, or Sponsor's negligence or breach of the Agreement."
[J] Subject injury
While indemnification and insurance have to do with loss and damage to the Institution, the issue of subject injury has to do with loss and damage to the subject. Sponsors readily agree to provide subject injury coverage if it is determined the injury is related to the investigational device, but who gets to make the determination? Good clinical practice tells us the principal investigator makes this determination.
Some sponsors like to add a clause that they will not pay for injuries until insurance is billed and denied. But billing third-party payors, whether Medicare or private insurance, should be at the Institution's discretion. If the injury is related to the medical device there should be no billing.
Some sponsors are concerned with injuries that are, in fact, attributable to the underlying illness. A solution is to qualify underlying illness by saying, "to the natural progression of the underlying illness."
Some sponsors try to limit their liability if the injury is attributable to the negligence of the study subject or the failure of the study subject to follow the instructions of the Principal Investigator. But such thinking is contrary to current ethical standards. Subjects are donating the use and study of their bodies for other people's gain; there may be little or no benefit to them beyond the satisfaction of contributing to the world's knowledge. Either the institution, sponsor, or third-party payors should bear the cost of their injury regardless of it origins.
IOM's suggested language is, "The Sponsor shall reimburse actual and reasonable medical expenses incurred in treating any injury or illness to a Study Subject that is directly related to the administration of the Investigational device or the proper performance of any other procedure, each in accordance with the Protocol and the Sponsor’s written instructions to the Institution (or to the extent that the Sponsor’s written instructions conflict with the Protocol, the Sponsor’s written instructions to the Institution only). The Sponsor is not required under this Section to provide compensation for (a) other injury- or illness-related costs (such as lost wages), (b) medical expenses that are paid for by a third party (provided that neither the Institution nor the Study Subject shall be obligated to seek reimbursement from a third party insurer), (c) medical expenses that are incurred as the result of a violation of the Protocol or other misconduct or negligence, in each case by any agent or employee of the Institution (including the Study Staff), or (d) medical expenses for injury or illness unrelated to the Investigational Device and unrelated to the proper performance of any other procedure required by the Protocol or Sponsor’s written instructions to the Institution." (6. IOM template)
Arizona offers a simpler suggestion, "Should a subject suffer any adverse effect caused by the Study drug/device/biologic, the Study procedures, or laboratory work required by the Protocol, Sponsor will pay for all medical and hospital costs required for the diagnosis and treatment of such adverse effect." (5. Arizona template)
[K] Best efforts
Consultants (such as Clinical Device Group) know that research projects are dynamic. No wise Institution, consultant, or research contractor should agree to work under time, cost, and performance constraints. Deadlines and results cannot be guaranteed. Furthermore, work product is constrained by the laws and standards of the United States.
One might think the Sponsor is left defenseless, but this is not the case. Institutions will agree to a "best efforts" clause, a contractual provision which requires the institution to use its highest efforts to perform its obligations and to maximize the benefits to be received by the sponsor. Sponsor's are obligated to terminate a site's participation in a study if non-compliances to protocol or regulations are discovered. And sponsors always have the right to terminate a study for business or ethical reasons. Cost overruns, project delays, or non-performance (of investigator or device) are all legitimate business or ethical reasons for terminating a study or an institution's participation in a study.
[N] Signatories
Industry sponsors sometimes don't realize the employee-employer relationship between investigators and investigative sites and they propose to have the investigator sign the CTA. They're also concerned about the performance of the investigator because of their financial investment in the trial.
A typical industry suggestion for the signatory clause is, "This Agreement is entered into by and among Sponsor, Investigative Site, and Principal Investigator." But if you think about it, an investigator—as an employee of the institution—has no legal authorization to sign the CTA.
A compromise clause is, "This Agreement is entered into by and between Sponsor and Investigative Site. The Principal Investigator shall conduct the trial as an employee of the institution and not as a party to this Agreement." Then the Principal Investigator is asked to sign the Agreement to indicate their understanding and intention to comply.
Sponsors and Institutions both have a vested interest in performing clinical research, and each party has much to gain from the process. By thinking through the issues and appreciating the needs of the other party, it is possible to come to an Agreement that is fair, balanced, and meets everyone's needs.
1. My thanks to Sean Perry, JD, Sr. Contract and Grant Officer, Office for Sponsored Research, Northwestern University, Chicago for his insights into this topic.
2. The format is taken from Clinical Trial Agreements, Weill Medical College of Cornell University, Office of Clinical Trials Administration. Contact CDG for link.
3. University-Industry Demonstration Partnership (UIDP), National Academy of Sciences, http://sites.nationalacademies.org/PGA/uidp/PGA_060368.
4. MAGI Model Clinical Trial Agreement, https://www.magiworld.org/standards/.
5. Template for Clinical Trial Agreement, University of Arizona Board of Regents, http://www.orca.arizona.edu/ctas.html.
6. Template for Clinical Trial Agreements, Developed by Jim Snipes, Covington & Burling LLP for the Institute of Medicine, April 2009. Contact CDG for pdf copy.
7. Guiding Principles for University-Industry Endeavors, National Academy of Science and the National Council of University Research Administrators and the Industrial Research Institute, April 2006.
Posted at 02:22 PM in Clinial Investigations, Clinical sponsors, Clinical Trial Procedures, Clinical Trials, Investigative sites | Permalink | Comments (2)