CSOG definition
Examples of CSOG in a sentence
Should the CSOG not unanimously agree on accepting or rejecting a major DMC recommendation, the dispute resolution process described in Section 2.4 will be followed.
The CSOG will review and approve the DMC’s membership and procedures.
Sponsor agrees that it will, in a timely manner consistent with applicable laws and regulations and the terms of the Study Agreement, provide the CSOG, MSKCC and any other Participating Sites with any information it obtains in the regarding the safety and/or the toxicity of any Study Product.
Study Specimens may be banked and used by the parties as expressly stated in the applicable Study Agreement or as otherwise agreed by the CSOG provided, the informed consents shall provided that Sponsor may also use any such materials (other than patient samples) to develop [***], including without limitation, Products.
All DMC open sessions reports related to a Clinical Study will be made available to the CSOG.
All such materials and any changes thereto must be approved by the CSOG as well as the IRB/PB.
If any party becomes aware that any organization or person involved in a Clinical Study is debarred, threatened with debarment, disqualified, threatened with disqualification, or suspended, that party will notify the other party and the CSOG immediately.
Prior to approving any new Clinical Study, the CSOG shall prepare and agree on a written Study Agreement for such Clinical Study.
If the CSOG is unable to resolve the issue within [***] business days after notification thereof or as soon as the CSOG determines it cannot resolve the issue, the issue will be referred promptly to the [***] of MSKCC and the [***] of Sponsor in writing including a brief description of the issue for resolution and any other supplemental material either party wishes to submit.
The CSOG will approve senior and first authorship on the initial joint publication of the results from each Clinical Study.