Timelines
Fill in the Blanks
Who is responsible
Associated Documents
Arrange in sequence
100
Within how many days of providing the draft report As per SOP-CO-13.04; Clinical Monitoring Plan, By when the CMP needs to be approved for a specific study: A. Prior to first site initiation B. Prior to first patient randomization C. Prior to first patient first visit D. Prior to first project meeting
C. Prior to first patient first visit
100
As per SOP-GM-06.04; Set up and Maintenance of TMF and SOF, A ___________ should be performed on any potential CRO who maintains the eTMF A. Thorough review of SOPs B. Pre-contract risk assessment C. Financial assessment D. Pre-contract visit
B. pre-contract risk assessment
100
Who is responsible to notify the Medical Monitor (MM) about any protocol deviation trends related to patient safety and take documented corrective actions in conjunction with the MM. A. PI B. Study Monitor C. CPM D. Functional Head
C. CPM
100
Which of the following information is not captured on AD-CO-20; Subject Screening and Enrolment Log? A. Version of the ICF signed B. Subject Date of birth C. Randomization number D. Date of completion/withdrawal
B. Subject Date of birth
100
Arrange in sequence (Vendor selection) A. Select one vendor B. Vendor evaluation C. Send request for proposal to at least 3 vendors D. Specify the services to be outsourced E. Identify the potential vendors F. Complete the agreement with vendor G. Identify outsourcing requirements H. Prepare Proposal comparison form
G-D-E-B-C-H-A-F
200
Within how many days SIV report should be signed off? A. within 10 Business days of SIV B. within 7 Business days of SIV C. within 15 Business days of SIV D. within 15 Business days of drafting the report
C. within 15 Business days of SIV
200
As per SOP-CO-20-03, Project management of GCRO studies, as and when required, CPM/SM/desinee speak to the appropriate vendor representatives to take an update of the vendor activities and document the key points of conversation, and any actions on the _________ A. Email communication B. contact report (AD-GM-40) C. Minutes of Meeting D. Vendor Oversight Checklist
B. contact report (AD-GM-40)
200
Who is responsible to send the photocopy of the Protocol Deviation tracker to data management for analysis purpose? A. CTA B. CPM/SM C. SM D. CPM
B. CPM/SM
200
Which of the following documents need to be filed as Original as per AD-CO-24; Sponsor Site file Index? A. Site Visit Log B. Subject Screening and Enrolment Log C. Translated PIS/ICF D. Investigator’s Brochure Receipt
D. Investigator’s Brochure Receipt
200
Arrange in sequence (Managing Protocol Deviations- A. Protocol Deviation (PD) identified B. SM to verify PD documentation in next SMV C. HCO to review the PD Form D. Medical Monitor (MM) to review the PD Form, complete it and send it back to SM/CPM E. PD Form completed by site on SM’s instruction F. SM to send completed form to PI G. CPM/SM to send the PD form to MM H. CPM to review the PD Form I. Site to notify PD to Ethics Committee
A-E-H-C-G-D-F-I-B
300
Within how many days an Onsite Feasibility Thank You letter/email (AD-CO-33), has to be sent to the site after returning from the Site Feasibility Visit. 10 business days 7 business days 10 calendar days 15 business days
10 business days
300
The in-house TMF/SOF must be set-up ____________________in order to ensure study specific documentation has an allocated filing location for ease of maintenance. ? A. Project allocation B. Trial team identification C. After protocol development D. prior to or immediately after the first study specific activities are conducted
D. prior to or immediately after the first study specific activities are conducted
300
Who is responsible to review the draft procedural documents for content, consistency, practicality, compliance with other procedural documents? A. QA designee B. Functional manager of the author C. CQM head/designee D. Line manager of the author
A. QA designee
300
AD-GM-80; TMF/SOF Plan is signed off by? A. CPM B. Functional Head C. Both A and B D. None of the above
D. None of the above
300
Arrange in sequence (Management of IP Phase II- IV trials) A. IP Dispensing/administration to study B. IP reconciliation by sponsor C. IP Receipt D. Request for IP E. Return/Destruction of unused IP F. Storage of retention sample (if applicable) G. IP accountability at site H. IP reconciliation by sponsor I. IP shipment to site J. IP storage at drug depot K. IP storage at site
D-C-J-B-K-A-G-E-I-H-F
400
What is the timeline to complete first TMF/SOF QC Checklist? A. within 6 month of first SIV B. within 6 months of 1st patient screened C. within 1 month of 1st patient enrolment D. within 6 months of 1st patient enrolment
D. within 6 months of 1st patient enrolment
400
As per SOP-CO-21, Project Management Oversight of Outsourced studies, CPM/designee should visit the vendor periodically (_____________) to ensure that the vendor complies with the activities and timelines defined in various agreements and document the vendor visit on AD-CO-18 Vendor Evaluation Checklist as a follow-up visit. A. every 6 months B. minimum once per study C. at least once per year D. no frequency defined
B. minimum once per study
400
Who is responsible to ensure that a Confidential Disclosure Agreement (CDA) has been executed and that the third party is contracted to work to Clinical R&D/PV procedures before releasing the Procedural documents to the CRO? A. Clinical R&D/PV personnel B. CPM C. QA designee D. CPM/Study Monitor
C. QA designee
400
Which of the following is not documented in Clinical Monitoring Plan A. Communication and reporting B. Case Report Form (CRF) C. Process of identifying new sites D. Site Management
C. Process of identifying new sites
400
Arrange in sequence (Management of IP Phase I trials) A. Destruction of unused/expired IP B. Filing of documents in TMF/SOF C. IP release checklist sign off D. Request for IP E. IP Reconciliation F. QP release/IP release at phase I unit by a phase I QP/physician G. Pre-shipment IP Checklist sign off H. IP Accountability I. Shipment to Phase I unit/site
D-C-G-I-F-H-E-A-B
500
Within how many days of providing the draft report Accompanied person has to discuss, in a private setting, the outcome of the visit with the SM and CPM? A. 10 business days B. 5 business days C. 7 business days D. 1 week
B. 5 business days
500
When eTMF is used in a Glenmark study, prior to signing contract with the CRO. These requirements should be checked for eTMF: 1. eTMF system is validated 2. Validation/qualification records are available and complete 3. Appropriate SOPs on maintaining eTMF are available. 4. eTMF is contemporaneous A. 1 and 2 B. All of the above C. 1, 2 and 3 D. Only 3
B. All of the above
500
If the clinical study report writing is performed by the vendor, who is responsible to review the report to ensure that the data reported is correct and to coordinate with the vendor to arrange for a review of the report by Glenmark MW Group and ensure all comments on the report are resolved prior to release of final report. A. CSR Author/Medical Writer B. CPM C. Clinical Outsourcing Manager D. CPM/Study Monitor
B. CPM
500
Original copy or a scanned copy on email of which AD is sent to the appropriate member of the Project Management team and one copy is sent to the responsible person at drug depot with another copy in the appropriate section of the Trial Master File (TMF). A. AD-CO-65; Pre-Shipment Checklist for IP B. AD-CO-64; Investigational Product Shipment Request C. AD-CO-66: Temperature and Humidity Log D. AD-CO-39 Investigational Product Order Request Form
D. AD-CO-39 Investigational Product Order Request Form
500
Arrange in sequence (Agreements) A. Finalize agreement in raise in LAAPA B. Obtain agreement template C. Post LAAPA approval, provide to approver D. Customize template when appropriate E. Obtain signed agreement from vendor F. Provide partially executed copies to vendor for sign off G. Approval of final copies H. Provide draft agreement to vendor for review I. Legal to review vendor comments and provide opinion J. Provide original agreement to the authorized Glenmark representative K. Make a copy of signed agreement & file in TMF
B-D-H-I-A-C-G-F-E-K-J
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