Make a List of Supporting Documents
For each Element, collect the policies and procedures that describe the practices your Organization follows to meet the Element, or indicate that the Element is not applicable to your Organization. When available, collect documents that verify that your Organization follows those practices. Most Elements can be supported by one to five documents, and some Elements may not have any supporting documents. In general, no more than 10 documents are necessary.
“Policies and procedures” refers to any written document that your Organization uses to define and communicate its practices, such as policies, procedures, standard operating procedures, checklists, guidelines, job descriptions, memoranda, forms, templates, strategic plans, websites, charters, by-laws, mission statements.
Construct an Element-by-Element Index to the Supporting Documents
List the supporting document for each Element. Reference the document’s number and provide a brief explanation. Use page numbers, paragraph numbers, line numbers, item numbers, chapter titles, and section headings to pinpoint the supporting information. For example, if you wish to point out information in your investigator’s manual that addresses conflicting interests, provide the page numbers, section numbers, and section titles as appropriate. For example: