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Vendor Selection Criteria
MDC_1.0 Vender Selection Criteria eTMF_eISF V 2 November 2020 copy_LC_Final_Review.pdf (201.11 KB)
Electronic Signature Attestation
MDC_v1.0 TPL-PM-3006_Electronic Signature Attestation_v1_30NOV2017_LC_Final_Review.pdf (140.66 KB)
Letter for Certification
MDC_v1.0 TPL-PM-3007_Letter for Certification (letter to FDA)_v1_30NOV2017_LC_Final_Review.pdf (145.57 KB)
Vendor Audit Template
MDC_v1.0 Vendor Audit Template_LC_Final_Review.pdf (151.41 KB)
Vendor Selection Criteria
MDC_v1.0 Vendor Selection Criteria ePRO_eSOURCE_ eConsent April 2017_LC_Final_Review docx.pdf (215.31 KB)
Checking Regulatory Status of Investigators and Sub-Investigators
MDC_v1.0 WI-PM-3001_CheckingRegulatoryStatusofInvestigatorsandSub-I_v2_21DEC2017-signed copy(1)_LC_Final_Review.pdf (226.24 KB)
Generating and Using Electronic Certified Copies
MDC_v1.0 WI-PM-3007_Generating and Using Certified Electronic Copies_v1_21DEC2017-signed_LC_Final_Review.pdf (197.82 KB)
Certification for the Use of Electronic Signatures
MDC_v1.0 WI-PM-3010_Certification for the Use of Electronic Signatures_v2_22dec2017-signed_LC_Final_Review.pdf (166.71 KB)