SJREB SOP Booklet

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SOP MANUAL VERSION 3

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REFERENCES

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FORMS

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FORM 1.1 CONFIDENTIALITY-AGREEMENT-AND-COI

FORM 1.2 TRAINING-RECORD

FORM 1.1A  LETTER-OF-APPOINTMENT-INDEPENDENT-CONSULTANT

FORM 2.1  APPLICATION-FOR-INITIAL-REVIEW

FORM 2.2  PROTOCOL SUMMARY

FORM 2.2A WAIVER OF INFORMED CONSEN

FORM 2.2B CERTIFICATE OF EXEMPTION

FORM 2.3 PROTOCOL EVALUATION FORM

FORM 2.4 ICF EVALUATION FORM

FORM 2.5 RESUBMISSION FORM

FORM 2.6 ICF TEMPLATE

FORM 2.7 NOTIFICATION LETTER

FORM 2.8 APPROVAL LETTER

FORM 3.0 NOTIFICATION LETTER TEMPLATE

FORM 3.1 SERIOUS ADVERSE EVENT REPORT FORM

FORM 3.2 UNEXPECTED ADVERSE EVENT REPORTFORM

FORM 3.3 CIOMS FORM

FORM 3.4 SAE ASSESSMENT FORM

FORM 3.5 PROTOCOL VIOLATION DEVIATION FORM

FORM 4.0 REMINDER LETTER FORM

FORM 4.1 PROTOCOL AMENDMENT

FORM 4.2 PROGRESS REPORT

FORM 4.3A FINAL REPORT FORM

FORM 4.3B CERTIFICATE OF COMPLETION

FORM 4.4 SITE VISIT REPORT FORM

FORM 4.5 COMMUNICATION RECORD FORM

FORM 5.1 AGENDA TEMPLATE

FORM 5.2 MEETING MINUTES TEMPLATE

FORM 5.3 FILE REQUEST LOG