Sponsor-Investigators

Batches should be tailor-made for the proposed trial, and should be labelled with information as appropriate regarding the product, sponsor, investigator, subject and trial, together with the statement For clinical trial use only . In addition, where the medicine will be used outside ofthe clinical site, the statement Keep out of reach of children should be added. There should be full accountability for the distribution, storage and fate of the drug product at both the manufacture and trial sites. 

Signed agreement between involved parties -CRO, sponsor, investigator, institution... 

Table 1 General Responsibilities for Sponsors, Investigators, and Institutional Review Board... 

The following instructions address only the administrative aspects of preparing and submitting an IND and are intended primarily to provide assistance to individual Sponsor-Investigator applicants, not pharmaceutical companies. 

This section is to be completed by pharmaceutical firms that are conducting clinical studies in support of a marketing application. Sponsor-Investigators need not complete this section. 

Numbering of submissions is primarily intended for pharmaceutical firms. Sponsor-Investigators do not have to complete this section. 

This section does not pertain to a Sponsor-Investigator. 

For a pharmaceutical firm, the name of the person responsible for monitoring the conduct of the clinical investigation and reviewing and evaluating safety information should be entered. For Sponsor-Investigator INDs, the investigator has this responsibility. 

For an IND sponsored by a pharmaceutical firm or research organization, the name of the sponsor s authorizing representative would be entered, that individual must sign the form For a Sponsor-Investigator IND, and the Sponsor-Investigator should be named and must sign the form. 

Form FDA 1572. Copies of Form FDA 1572 with its attachments may be sent by the Sponsor-Investigator to the FDA to satisfy Form FDA 1571, box 12, item 6 b-d. Information can be supplied in the form of attachments (such as a curriculum vitae) rather than entering that information directly onto the form, but this should be so noted under the relevant section numbers. 

Universities may, however, cany out veiy small pioneering studies on an investigator-sponsored investigational new drug (IND) procedure with FDA approval. 

In general, the term sponsor refers to a commercial manufacturer that has developed a product in which it holds the principal financial interest. A sponsor may also be a physician, commonly called a sponsor-investigator , which federal regulations define as an individual who both initiates and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed. ... 

General information This includes protocol titles, name, title and address of sponsor, investigator, and qualified physician. 

The DCO is the point person for daily clinical operations. He is the individual who interfaces with sponsors, investigators, study coordinators and other professional staff on a regular basis to oversee clinical and budgetary status of ongoing and upcoming studies. Because of the intense, close attention to detail that the job demands, it makes sense to fill this position with a highly detail-oriented individual with an understanding of the clinical trials process. 

To offer sponsors, investigators, and patients a guaranteed quality in the clinical trial process, by executing a correct reception, storage, and dispensation of the investigational drug. 

The expected return of oil price increases over the next decade will again spur investigation into conversion processes for alternative fuel sources such as coal. Coal gasification will produce substantial amounts of carbon dioxide as a by-product. If this carbon dioxide could be converted economically to methanol or methane, established zeolite catalytic processes could convert these intermediates to gasoline. Furthermore, concern about providing a substitute for natural gas to the established gas pipelines has led the Gas Research Institute to sponsor investigation of carbon dioxide conversion selectively to methane (2). 

In 1982, Merck allowed several clinicians to file individually sponsored investigational new drug applications (INDs) for lovastatin in order to treat patients with severely high cholesterol unresponsive to existing therapies. The drug dramatically lowered LDL cholesterol with very few observed side effects. The results prompted Merck to reinstitute animal studies, and in May 1984 the company filed a commercial IND, allowing lovastatin to enter phase I clinical trials. 

Sponsor-Investigator providing the IND number assigned, date of receipt of the original application, address where future submissions to the IND should be sent, and the name and telephone number of the FDA person to whom questions about the application should be directed. The IND studies shall not be initiated until 30 days after the date of receipt of the IND by the FDA. The sponsor may receive earlier notification by the FDA that studies may begin. 

Recall procedures should be understood by the sponsor, investigator and monitor in addition to the person(s) responsible for recalls, as described in the guide on GMP (2, pages 28-29). 

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