Publications & Reports

Accelerated Clinical Trial Agreement (ACTA)

The Accelerated Clinical Trial Agreement (ACTA) was prepared with the intent to facilitate relationships with industry sponsors that are interested in expediting the contract process, thus optimizing lag time for research.

The underlying principles used in the construction of the ACTA are that it represents a straightforward and unambiguous position that clearly sets forth the regulatory and contractual obligations of both parties, and presents language while perhaps not ideal to either party, is acceptable to both.  An Accelerated Confidential Disclosure Agreement (ACDA) has also been created as a companion document to the ACTA.  Additional renditions of the ACTA (e.g., an ACTA for use with CROs) are also available on the following website.

Access the ACTA, ACDA, & Related Resources

 

The rationale behind the language used in ACTA is provided in the annotated ACTA.

Download Annotated ACTA

Copyright & Disclaimer

UIDP materials, which include publications, webinars, videos, and presentations, reflect an amalgamation of the experiences and knowledge of those who participate in UIDP activities. The views and opinions expressed in UIDP materials do not necessarily reflect the official policy or position of any individual organization or the UIDP. At no time should any UIDP materials be used as a replacement for an individual organization’s policy, procedures, or legal counsel. UIDP is not a lobbying organization, and UIDP materials are not intended to be used to influence government decisions.

All rights reserved. This member-created publication is intended for use by UIDP MEMBERS ONLY. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of UIDP. To view the written permission granted to member organizations, go to www.uidp.org.

Additional written permission may be granted to members, nonmembers, and/or participants in certain UIDP events. Additional permissions can be found in the UIDP materials to which they pertain.

For permission requests, write to UIDP at: 6156 St. Andrews Rd., Suite 207, Columbia, SC 29212.

Copyright © 2016 by University Industry Demonstration Partnership (UIDP)

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The rationale behind the language used in ACDA is provided in the annotated ACDA.

Download Annotated ACDA

Copyright & Disclaimer

UIDP materials, which include publications, webinars, videos, and presentations, reflect an amalgamation of the experiences and knowledge of those who participate in UIDP activities. The views and opinions expressed in UIDP materials do not necessarily reflect the official policy or position of any individual organization or the UIDP. At no time should any UIDP materials be used as a replacement for an individual organization’s policy, procedures, or legal counsel. UIDP is not a lobbying organization, and UIDP materials are not intended to be used to influence government decisions.

All rights reserved. This member-created publication is intended for use by UIDP MEMBERS ONLY. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of UIDP. To view the written permission granted to member organizations, go to www.uidp.org.

Additional written permission may be granted to members, nonmembers, and/or participants in certain UIDP events. Additional permissions can be found in the UIDP materials to which they pertain.

For permission requests, write to UIDP at: 6156 St. Andrews Rd., Suite 207, Columbia, SC 29212.

Copyright © 2016 by University Industry Demonstration Partnership (UIDP)

I Agree

Background on the ACTA & ACDA

How We Began

Contract negotiations are a complex process and are often identified as a major barrier to efficient study initiation. Data from a 2010 CTSA Contracts Processing study described an average negotiation time of 103 days, which was reduced to 73 days if a “master agreement” was utilized. As an attempt to remedy this hurdle, the CTSA Master Contracts Working Group, made up of legal experts from ~25 CTSA institutions, collaborated with industry and the University Industry Demonstration Partnership to develop a standardized clinical trial agreement – a single agreement to be used (voluntarily) by each participating institution and sponsor, to reduce contract negotiations for industry sponsored multi-site studies, specifically for Phase 2b and Phase 3 Clinical Trials.

Where We Have Been

The ACTA was prepared with the intent to facilitate relationships with industry sponsors that are interested in expediting the contract process, thus optimizing lag time for research. The underlying principles used in the construction of the ACTA are that it represents a straightforward and unambiguous position that clearly sets forth the regulatory and contractual obligations of both parties, and presents language while perhaps not ideal to either party, is acceptable to both.

Where We Are

The ACTA has now been reviewed by several external sources (Pfizer, Epizyme, Shire, Eli Lilly) and feedback has been incorporated.More than 50 organizations representing over 225 sites, including academic medical centers, universities, hospitals and physician practices, have agreed that the terms would be acceptable. Outreach has begun to approach Industry sponsors to initiate opportunities to pilot the use of the ACTA with 5 pilots currently active.