ISF Master Reference List_DO NOT EDIT_downloaded.xlsm |
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| A | B | C | D | E | F | G | H | I | J | K |
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1 | Section | Section Sub Code | Document Name | Version | Dated | In eISF | In Final ISF | At Location | eCopy Saved | Comments | Date Master List Updated |
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2 | 0
TOC & Study Team Contact Sheet | 0.01 | Table of Contents | V1 | 11-Oct-21 | Yes | Yes | | | | |
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3 | 0.02 | Study Team Contact Sheet | V1 | O4Oct21 | Yes | Yes | | | | |
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4 | 1
Site Personnel Documentation | 1.01 | Site Signature and Delegation of Authority Log | V1 | O4Oct21 | Yes | Yes | | | | |
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5 | 1.02 | CV and Medical Licenses | | | | | | | | |
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6 | 1.02 | PI CV | | | | | | | | |
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7 | 1.02 | SC CV | | | | | | | | |
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8 | 1.02 | Sub-I CV | | | | | | | | |
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9 | 02
Site Procedural Documents and Forms | 2.01 | Site Procedural Documents and Foms | | | | | | | | |
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10 | 2.02 | Site Recruitment and Activation Plan | | | | | | | | |
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11 | 2.02 | SRRP Attachment E | V1 | 4-Oct-21 | Yes | Yes | | | | |
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12 | 2.03 | Source Data Agreement | V1 | 18-Nov-21 | Yes | Yes | | | | |
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13 | 2.04 | EMR Checklist | V1 | 15-Sep-20 | Yes | Yes | | | | |
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14 | 2.04 | EMR Certified Copy Memo | | | Yes | Yes | | | | |
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15 | 2.04 | EMR Permission to Access Form | | | Yes | Yes | | | | |
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16 | 03
Study Protocol | 3.01 | Study Protocol | V1 | 26-Apr-21 | Yes | | | | | |
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17 | 3.01 | Final and Amendments | | | | | | | | |
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18 | 3.01 | Protocol Singature Page | V1 | 18-Aug-21 | Yes | | | | | |
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19 | 3.01 | Study Schedule Flowchart | | | | | | | | |
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20 | 3.01 | Inclusion/Exclusion Checklist | V1 | 18-Oct-21 | Yes | | | | | |
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21 | 3.02 | Study Procedure Manuals | | | | | | | | |
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22 | 3.02 | 6MWT guideline & checklist | V1 | 9-Sep-21 | Yes | | | | | |
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23 | 3.02 | Blank eCRF | V1 | 5-Oct-21 | | | | | | |
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24 | 3.02 | EDC Completion Guidelines | V1 | 5-Oct-21 | Yes | | | | | |
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25 | 3.02 | RHC Guideline | | | N/A | N/A | | | | |
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26 | 3.02 | RHC Worksheet | V1 | 12-Aug-21 | N/A | N/A | | | | |
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27 | 04
ICF and Subject Materials | 4.01 | Informed Consent, including translations (if any) | | | | | | | | |
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28 | 4.01 | Main ICF V1 | V1 | 15-Sep-21 | | | | | | |
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29 | 4.01 | Newborn ICF V1 | V1 | 15-Sep-21 | | | | | | |
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30 | 4.01 | Greenphire ICF V1 | V1 | 10-Sep-21 | | | | | | |
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31 | 4.01 | Pregnant Partner NTF from Advarra | V1 | 9-Nov-20 | Yes | Yes | | | | |
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32 | 4.01 | Subject Information Sheet and Informed Consent Form | | | | | | | | |
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33 | 4.01 | Signed Informed Consent Forms, if not filed with Source Documents or under 19.02 | | | | | | | | |
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34 | 4.02 | Subject Materials, including translations (if any) | | | | | | | | |
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35 | 4.02 | Patient Letter | V1 | 20-Jul-21 | Yes | Yes | | | | |
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36 | 4.02 | PCP Participant enrollment letter | V1 | 20-Jul-21 | Yes | Yes | | | | |
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37 | 4.02 | Recruitment poster | V1 | 8-Jul-21 | Yes | Yes | | | | |
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38 | 4.02 | Study introduction trifold (for subjects) | V1 | 22-Jul-21 | Yes | Yes | | | | |
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39 | 4.02 | Thank You Card | V1 | 20-Jul-21 | Yes | Yes | | | | |
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40 | 4.02 | Patient Card | V1 | 2-Jul-21 | Yes | Yes | | | | |
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41 | 4.02 | Borg CR10 Instructions | V1 | N/A | Yes | Yes | | | Not Printed in Binder - Provided by Jumo Health | |
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42 | 4.02 | Borg CR10 Scale | V1 | N/A | Yes | Yes | | | Not Printed in Binder - Provided by Jumo Health | |
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43 | 4.03 | Greenphire Travel and Reimbursements | | | | | | | Also available in Spanish if applicable | |
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44 | 4.03 | Greenphire ClinCard Cardholder RideShare FAQ | V1 | 18-Apr-19 | Yes | Yes | | | | |
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45 | 4.03 | Greenphire ClinCard Carrier English | V5 | Sep-20 | Yes | Yes | | | | |
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46 | 4.03 | Greenphire ClinCard Travel Ref Guide | V3 | 11-Oct-16 | Yes | Yes | | | | |
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47 | 4.03 | Greenphire ConneX USA Travel Contact Card | V1 | Jan-19 | Yes | Yes | | | | |
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48 | 5
Regulatory | 5.01 | Site Specific Regulatory Submission/Approval/Acknowledgement | | | Folders are present but all information within will be provided and filed by site | Folders are present but all information within will be provided and filed by site | | | | |
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49 | 5.02 | FDA 1572 | V1 | 11-Aug-21 | | | | |
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50 | 5.03 | Financial Disclosure | | | | | | |
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51 | 5.03 | PI FDF - | V1 | 11-Aug-21 | | | | |
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52 | 5.03 | Sub-I FDF - | V1 | | | | | |
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53 | 5.03 | Sub-I - | V1 | | | | | |
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54 | 5.04 | Other Site Specific Approvals | | | | | | |
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55 | 5.05 | Regulatory Correspondence | | | | | | |
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56 | 6
Ethics (IRB) | 6.01 | Ethics Initial CTA Submission/Approval/Acknowledgment | | | Folders are present but all information within will be provided and filed by site | Folders are present but all information within will be provided and filed by site | | | | |
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57 | 6.02 | Ethics Amendment CTA Submission/Approval/Acknowledgment | | | | | | |
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58 | 6.03 | Ethics Progress/Periodic/Clinical Study Reports Submission/Approval/Acknowledgment | | | | | | |
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59 | 6.03 | Initial IRB Approval | | | | | See IRB Letters Tab | |
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60 | 6.03 | Ethics Study Deviation(s) Submission/Approval/Acknowledgment | | | | | | |
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61 | 6.03 | Ethics SAE Submission/Approval/Acknowledgment | | | | | | |
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62 | 6.04 | Ethics Expedited Safety Report Submission/Approval/Acknowledgment | | | | | | |
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63 | 6.05 | End of Study Submission/Approval/Acknowledgment | | | | | | |
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64 | 6.06 | Ethics GCP Compliance Statement | | | | | | |
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65 | 6.07 | Ethics Documenatation of Non-Voting Status (if not inlcuded in Submission/Approval/Acknowledgment) | | | | | | |
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66 | 6.08 | Ethics Correspondence | | | | | | |
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67 | 7
Legal & Financial Documentation | 7.01 | CDA | | | Folders are present but all information within will be provided and filed by site | Folders are present but all information within will be provided and filed by site | | | | |
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68 | 7.02 | Indemnification | | | | | | |
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69 | 7.03 | Clinical Trial Agreement(s) Investigator and site, including translations | | | | | | |
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70 | 7.04 | Clinical Trial Agreement(s) Site Departments and Service Providers, including translations | | | | | | |
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71 | 7.05 | Other Legal and Financial documentation (W9, DPA, PAF if not included in CTA) | | | | | | |
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72 | 7.06 | Invoices and Payment Information | | | | | | |
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73 | 7.07 | Insurance | | | | | | |
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74 | 7.08 | Legal and Financial Corespondence | | | | | | |
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75 | 8
Safety | 8.01 | Investigator Brochure/Investigational Medicinal Product Dossier/SPC, translations (if any) | V16 | 17-Apr-21 | Yes | Yes | | | | |
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76 | 8.02 | SAE and Pregnancy reporting forms | | | | | | | | |
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77 | 8.02 | Exposure During Pregnancy Reporting Form | V1 | N/A | Yes | Yes | | | | |
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78 | 8.02 | SAE Reporting Form | V1 | N/A | Yes | Yes | | | | |
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79 | 8.03 | Expedited Safety Reports | | | | | | | | |
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80 | 8.04 | PsiXchange Reference Guideline | | | Yes | Yes | | | | |
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81 | 9
Laboratory (Central and Local) | 9.01 | Laboratory Manual (Central laboratory) | V1 | 13-Nov-21 | Yes | Yes | | | | |
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82 | 9.01 | Reference Ranges | | | | | | | | |
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83 | 9.01 | CV of Laboratory Head | | | | | | | | |
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84 | 9.01 | PPD Laboratories Collection Flow Chart | V1 | 14-Sep-21 | Yes | Yes | | | | |
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85 | 9.02 | Reference Rangse/Normal Values (Local Lab) | N/A | 24Sug21 | | | | | | |
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86 | 9.03 | Accreditation Records and/or Head of Laboratory CV (Local laboratory) | | | | | | | | |
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87 | 9.04 | Training / Meeting Materials | | | | | | | | |
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88 | 9.04 | Preclarus Lab Data Portal User Guide | V2 | 20-Jul-18 | Yes | Yes | | | | |
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89 | 9.05 | Bio-analytical Documentation | | | | | | | | |
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90 | 9.06 | Labeling | | | | | | | | |
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91 | 9.07 | Lists/Logs (e.g. record of retained body fluids/tissue samples (if any), | | | | | | | | |
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92 | 9.07 | Lab Samples Storage Temp Log | V1 | 11-Oct-21 | Yes | Yes | | | | |
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93 | 9.07 | Lab Samples Storage_Subject-Specific | V1 | 11-Oct-21 | Yes | Yes | | | | |
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94 | 9.07 | Shipment records | | | | | | | | |
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95 | 9.08 | Laboratory Correspondence | | | | | | | | |
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96 | 10
Vendors/Local Department(s)/Third Party Provider(s) | 10.01 | Almac IRT | | | | | | | | |
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97 | 10.01 | Vendor Manual/ IxRS User Guides | V1 | 5-Nov-21 | Yes | Yes | | | | |
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98 | 10.01 | Training/Meeting Materials | | | | | | | | |
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99 | 10.01 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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100 | 10.02 | BAIM Institute | | | | | | | | |
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101 | 10.02 | BAIM Manual | V1 | 3-Nov-21 | Yes | Yes | | | | |
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102 | 10.02 | Training/Meeting Materials | | | | | | | | |
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103 | 10.02 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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104 | 10.03 | BioTel Research | | | | | | | | |
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105 | 10.03 | ECG acquisition guide | V1 | 3-Aug-21 | Yes | Yes | | | | |
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106 | 10.03 | ECG site information form | V1 | 17-Jun-21 | Yes | Yes | | | | |
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107 | 10.03 | ECHO data transmittal form | V1 | 30-Aug-21 | Yes | Yes | | | | |
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108 | 10.03 | ECHO participant screening guide | V1 | 30-Aug-21 | Yes | Yes | | | | |
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109 | 10.03 | ECHO participant screening guide | V2 | 8-Feb-22 | Yes | Yes | | | | 15-Feb-22 |
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110 | 10.03 | ECHO quick reference guide | V1 | 27-Jul-21 | Yes | Yes | | | | |
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111 | 10.03 | ECHO site questionnaire | V1 | 23-Aug-21 | Yes | Yes | | | | |
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112 | 10.03 | Ambra eTransfer Site User Guide | V1 | N/A | | | | | | |
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113 | 10.03 | QMS Site User Guide | V1 | 10-Oct-20 | | | | | | |
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114 | 10.03 | Site Validation/Qualification | | | | | | | | |
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115 | 10.03 | ECG Test Transmission Successful Email | | No | | Yes | | | | |
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116 | 10.03 | ECHO - First Participant Ready Notification | | No | | Yes | | | | |
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117 | 10.03 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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118 | 10.03 | ECHO Peer Training Log | V3 | 2-Jun-20 | Yes | Yes | | | Note: It says to fax a copy of the log to BTR at the bottom of the form, this is not required. The site maintains the log for their records | 24-Feb-22 |
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119 | 10.03 | ECG Peer Training Log | V3 | 2-Jun-20 | Yes | Yes | | | Note: It says to fax a copy of the log to BTR at the bottom of the form, this is not required. The site maintains the log for their records | 24-Feb-22 |
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120 | 10.04 | Greenphire | | | | | | | | |
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121 | 10.04 | Welcome to Clincard | V1 | N/A | Yes | Yes | | | | |
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122 | 10.04 | Welcome to ConneX | V1 | Feb-20 | Yes | Yes | | | | |
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123 | 10.04 | ClinCard Reference Guide for Coordinators | V7.3 | Oct-19 | Yes | Yes | | | | |
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124 | 10.04 | ConneX Travel Reference Guide for Coordinators | V2 | Dec-21 | Yes | Yes | | | | |
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125 | 10.04 | Grenphire New User Training Handout | N/A | N/A | Yes | Yes | | | | |
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126 | 10.04 | Greenphire Generic ClinCard | V3 | Jun-18 | Yes | Yes | | | | |
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127 | 10.04 | Greenphire ClinCard Messgae Template | V5 | Feb-18 | Yes | Yes | | | | |
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128 | 10.04 | Greenphire CliCard Rideshare Message Template | V1 | Apr-19 | Yes | Yes | | | | |
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129 | 10.04 | Patient Materials (filed in section 4.02) | | | | | | | | |
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130 | 10.04 | Training/Meeting Materials | | | | | | | | |
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131 | 10.04 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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132 | 10.05 | Jumo Health | | | | | | | | |
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133 | 10.05 | Site Material | N/A | N/A | N/A | N/A | | | | |
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134 | 10.05 | Patient materials (filed in section 04.02) | N/A | N/A | N/A | N/A | | | | |
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135 | 10.05 | Training/Meeting Materials | N/A | N/A | N/A | N/A | | | | |
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136 | 10.05 | Lists/Logs/Vendor Correspondence | N/A | N/A | N/A | N/A | | | | |
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137 | 10.06 | Medable/PPD Digital | | | | | | | | |
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138 | 10.06 | Medable Site Guide | V1 | 22-Sep-21 | Yes | Yes | | | | |
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139 | 10.06 | Training/Meeting Materials | | | | | | | | |
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140 | 10.06 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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141 | 10.07 | Medidata Rave | | | | | | | | |
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142 | 10.07 | eCRF guideline | V1 | 5-Oct-21 | Yes | Yes | | | | |
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143 | 10.07 | eCRF guideline | V2 | 2-Dec-21 | | | | | | |
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144 | 10.07 | eCRF guideline | V3 | 23-Feb-22 | Yes | Yes | | | | 2-Mar-22 |
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145 | 10.07 | Training/Meeting Materials | | | | | | | | |
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146 | 10.07 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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147 | 10.08 | PRA Safety Reporting System: psiXchange | | | | | | | | |
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148 | 10.08 | Reference Guideline V2.0 | V2 | 6-Aug-20 | Yes | Yes | | | | |
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149 | 10.08 | Reference Guideline V2.0 | V3 | 4-Nov-20 | | | | | | |
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150 | 10.08 | Training/Meeting Materials | | | | | | | | |
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151 | 10.08 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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152 | 10.09 | Local Department(s)/Third Party Provider(s) | | | | | | | | |
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153 | 10.09 | Training/Meeting Materials | | | | | | | | |
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154 | 10.09 | Lists/Logs/Vendor Correspondence | | | | | | | | |
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