Polaris

SOP# MON-009.0CompanyEffective Date: DD/MMM/YY3. Financial Disclosure FormsA Financial Disclosure Form, provided by the sponsor, should be signed by theInvestigator and each Subinvestigator. If required by the sponsor, a signedFinancial Disclosure Form will also be obtained from the Study Coordinator.4. Investigator Brochure or Package InsertAll revised versions of the brochure that are used during the clinical study shouldbe included in the study file notebook. The earlier version of the brochure shouldnot be discarded.5. Protocol and Amendmentsa. The Monitor will ensure that the protocol is signed and dated by theInvestigator indicating his/her agreement to conduct the study according to theprotocol. Drafts of protocols and protocol amendments do not need to beretained in the study file.b. As they are generated, signed and dated (original) protocol amendmentsshould be attached to back of the protocol. If the sponsor generates a revisedprotocol that incorporates the amendment changes, this version of the protocolshould be included in the study file notebook. However, previous approvedversions should not be discarded.c. Drafts of the protocol and protocol amendments should not be included in thefile unless they are accompanied by a memo to the file from the StudyMonitor with an explanation.6. IRB Membership Rostera. Prior to the shipment of study drug and supplies, the Monitor must obtain anIRB roster of voting members to ensure that the IRB is a valid board.b. If the IRB refuses to release a membership roster, the Monitor will obtain theDepartment of Health and Human Services (DHHS) assurance number (ifthere is one) or a written statement from the IRB chairman which states thatthe IRB complies with the requirements of 21 CFR Part 56.c. During the course of the study, the Monitor should ensure that this list remainscurrent; however, copies of outdated lists should not be discarded.7. IRB Approval of the Protocol and Consenta. Each IRB listed in section 5 of FDA Form 1572 must provide an approvalletter.b. The Study Monitor should review the content of the approval to ensure thefollowing:i. It contains the protocol number, protocol title, or reasonable informationto determine specifically which protocol (and version) was approved.ii. It is provided on the IRB or institution letterhead and contains someidentifying information to associate it with the IRB listed in section 5 ofFDA Form 1572.iii. The date of the approval is after the date of the final protocol.iv. The approval is addressed to the Principal Investigator.MON-009.0.doc© 2004 by CRC Press LLC