Suggested Electronic Document Retention And Nomenclature

This paper is intended to provide an initial framework for the filing of electronic documents within Vestigo and offer suggestions for potential nomenclature. This may be helpful for the initial consideration of developing a site-specific policy and procedure for scanning, validation, and organization of electronic documents.

Protocol Documents

Protocol Information

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Protocol, Amendments	YYYYMMDD_Protocol_V	Protocol_V_YYYY.MM.DD
Pharmacy Manual, Amendments	YYYYMMDD_PharmManual	PM_V_YYYY.MM.DD
Manual of Procedures	YYYYMMDD_MOP	MOP_{_}YYYY.MM.DD
Investigator’s Brochure	YYYYMMDD_IB_V	IB_V_YYYY.MM.DD
MSDS	YYYYMMDD_MSDS	MSDS_YYYY.MM.DD
IXRS Manual	YYYYMMDD_IXRS_Manual	IXRS_Manual_{_}YYYY.MM.DD

YYYYMMDD Date format to reference the date of issue.

Dispensing guidelines

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Pharmacy Summary Sheet	YYYYMMDD_SummarySheet_V	SummarySheet_V_YYYY.MM.DD
Fast Facts	YYYYMMDD_FastFacts	FastFacts_V_YYYY.MM.DD
Pharmacy Manual, Amendments	YYYYMMDD_PharmacyManual	PharmacyManual_V_YYYY.MM.DD
Dosing worksheets, nomograms	YYYYMMDD_Dosing_V	Dosing_YYYY.MM.DD
Patient information sheets	YYYYMMDD_PatientInfo	PatientInfo_YYYY.MM.DD
Oral Counseling Guides	YYYYMMDD_Counseling	CounselingGuide_YYYY.MM.DD.

YYYYMMDD Date format to reference the date of issue.

Communication/Memos

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Expiration Date Memos / Retest Date Memos	YYYYMMDD_Retest_Lot#	Expiry_YYYY.MM.DD_Lot#
E-mails/Correspondence	YYYYMMDD_Email_(topic)	COMM_YYYY.DD.MM_(topic)
Monitoring Visit Summary, Monitor Visit Follow-up	YYYYMMDD_MonitorFU	IMV_FU_YYYY.MM.DD
Note To Files	YYYYMMDD_NTF	NTF_YYYY.MM.DD

YYYYMMDD Date format to reference the date of correspondence.

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Documents Visible on Patient/Subjects Tab

Documents that are to be viewed or referenced before processing an order and dispense.

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Pharmacy Summary Sheet, Information Sheet, or Fast Facts	YYYYMMDD_Summary_V	Summary_Sheet_YYYY.MM.DD
Dosing Guidelines	YYYYMMDD_Dosing	Dosing_Guide_YYYY.MM.DD
Preparation Logs or Worksheets	YYYYMMDD_PrepWorksheet	IP_Prep_Worksheet_YYYY.MM.DD
Randomization Table	YYYYMMDD_Randomization_Table	Randomization_Table_YYYY.MM.DD

YYYYMMDD Date format to reference the date of issue.

Order Documents Visible on Dispense

Documents that are attached to an Order and will pop-up when that order is selected during dispense. Viewing the document will open a separate browser tab so that important information can be accessible while processing a dispense.

If an alternative pathway to process or verify an order is utilized, such as through an Alert or EMR queue, this location allows for study-specific documents to be viewed and accessible without navigating to the Patient/Subjects tab.

Suggested uses include:

Attach or create a file with Pharmacy Summary Sheet information
Create files to alert unique requirements related to the dispense of the specific order
Create files with imported Vestigo Templates to display preparation instructions
Attach Drug Preparation Worksheets or Logs that are to be printed and completed
Attach Patient Information Sheets or Counseling Guides that are to be printed or completed
Dosing Nomograms
Dosing Guidelines or Modifications

Other

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Budget Estimates	YYYYMMDD_Budget	Budget_YYYY.MM.DD
IRB Approvals	YYYYMMDD_IRB_Approval	IRB_Approval_YYYY.MM.DD

YYYYMMDD Date format to reference the date of correspondence

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Master Protocol Forms

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Drug Reorder Form	YYYYMMDD_Drug_Order_Form	Reorder_Form_YYYY.MM.DD
Temperature Excursion Form	YYYYMMDD_TEForm	TempExcursion_Form_YYYY.MM.DD
Product Complaint Form	YYYYMMDD_ProductComplaint	IP_Complaint_YYYY.MM.DD
Drug Preparation Worksheet	YYYYMMD_PrepLog	DrugPrepLog_YYYY.MM.DD

YYYYMMDD Date format to reference the date of issue.

Transaction Documents

Multiple files can be managed and associated with a single transaction. Depending on site-specific policies and workflows, many of the documents related to the transaction may be scanned together as a single file and then uploaded into Vestigo.

Prescriptions

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
MD Order, Prescriptions	YYYYMMDD_RX_PSN	RX_PSN_YYYY.MM.DD
Kit/IXRS allocation	YYYYMMDD_IXRS_PSN	Dispense_PSN_YYYY.MM.DD
Correspondence regarding the specific dispense (dosing modification, quantity dispensed, unscheduled visit)	YYYYMMDD_COMM_(topic)	COMM_YYYY.MM.DD_(topic)

YYYYMMDD Date format to reference the date of dispense.

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Shipping Receipts

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Shipping Receipt, Packing List, Invoice	YYYYMMDD_Shipment	Invoice_YYYY.MM.DD
IXRS Shipment Confirmation	YYYYMMDD_Confirmation	Shipment_IXRS_YYYY.MM.DD
In-transit Temperature Monitoring	YYYYMMDD_TempTale	TempTale_YYYY.MM.DD
Sponsor correspondence unique to shipment (e.g., evaluation of in-transit temp excursion)	YYYYMMD_PrepLog	DrugPrepLog_YYYY.MM.DD

YYYYMMDD Date format to reference the date of receipt.

Patient Documents

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Consent	YYYYMMDD_Consent_PSN	Consent_PSN_YYYY.MM.DD
Enrollment, registration, cohort information	YYYYMMDD_Registration_PSN	Enrollment_PSN_YYYY.MM.DD
Randomization Assignment	YYYYMMDD_Randomization_PSN	Randomization_PSN_YYYY.MM.DD

YYYYMMDD Date format to reference the date of correspondence.

Temperature Logs

Types of Documents	Nomenclature Suggestions	Nomenclature Suggestions
Temperature Record	YYYYMMDD_Location	Location_Temp_Log_YYYY.MMDD
Calibration Certificates	YYYYMMDD_TEForm	TempExcursion_Form_YYYY.MM.DD
Temperature Excursion Reports, NTFs	YYYYMMDD_NTF_TE	NTF_TE_YYYY.MM.DD

YYYYMMDD Date format to reference the date of logs.

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