What you missed at the: 2 nd Clinical Trials Inspection Readiness Summit August 2013 Philadelphia, PA

Transcription

1 What you missed at the: 2 nd Clinical Trials Inspection Readiness Summit August 2013 Philadelphia, PA For a complete overview download the 2013 Executive Summary

2 Notice of Inspection US FDA European Regulatory Authorities Little or no notice given to sponsors Inspection typically last 1-2 weeks (routine) Agenda issued ~30 days prior to onset of inspection Sponsor notified usually 4-5 months in advance FDA 482 issued at onset of inspection and 483 issued at close if there are observations Inspection typically lasts about a week

3 Functional Area Preparation General Inspection Readiness Documentation Assure job descriptions, CVs and training records are available and up to date for all trial staff Gather current organization al charts for all functional areas Identify key trial staff and vendors, including contracts, to support the trial/program Create story boards for key issues from a trial/program Trial-Related Documentation Assure key trial plans are filed in the trial master file and readily able to be retrieved Assure correspondin g documentatio n to demonstrate completion of plans is filed Assure documentatio n of key issues is complete and filed in the trial master file

4 Inspection Styles US FDA GCP Inspections Usually based on submissions under review Routine or For Cause Previous selection criteria included: Highest enrollers Inspection naive Data anomalies Sponsor inspection Site inspection Focus includes: Review of data Interviews to clarify questions about data EU EMA GCP Inspections Have been in place for a while, but now with increasing frequency EMA inspections pre or post-approval Sponsor Inspection Site inspections Focus includes: Interviews to discuss process and systems Verification of interviews through review of data FUTURE: More Joint US, EU, and/or other global RA inspections; Significant training & Sharing of information between agencies

5 Examples of Common Trial Docs Requested Training: 1. Training records/ retraining for Sponsor/CRO and site personnel 2. Training materials used to train all personnel 3. Listing by site of how training was completed 4. Internal and external Training logs, presentations, Investigator Meeting attendance logs, Virtual meeting WebEx logs Investigational Product: 1. Packaging design and labeling documentation 2. Product quality complaints with resolutions 3. Handling instructions for IP with unique handling requirements (e.g. cold chain) Audits: 1. Audit plans for selected studies/ programs Committees: 1. Independent data monitoring committee charter, membership & Meeting reports/minutes 2. Adjudication committee charter 3. Adjudication committee manual provided to PIs, including guideline & policy on independence 4. Central ECG reviewer guidelines 5. Central imaging charter Other: 1. Contracts for vendors (e.g. CROs, AROs, IVRS, ECG, Imaging) 2. SAE reporting flow, who is responsible for the safety database (CRO, alliance partner, JnJ) and listing of SAEs reported, Safety reports for specific sites 3. Financial Disclosure and documentation of review of individuals who reported financial interest 4. Documentation on registration and reporting of study results in Clinicaltrials.gov (US only)

6 Conducting the TMF/Document QC Step 1) Inventory the documents present against the TMF tracking.» What if no tracking is available?» Document the deviation and establish a tracker.» Your team will find this invaluable for many reasons:» Tracking/resolving outstanding items.» Assist with locating documents during inspection or inspection prep.

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13 Slide Credits Joseph Pollarine, Janssen R&D Jamie Provenzano-Gray, Janssen R&D Greg Vico, Janssen R&D Steven Talerico, Merck & Company Sarah Tucker, Phlexglobal Ross Pettit, AMAG Pharmaceuticals Katie Delaney, AMAG Pharmaceuticals Amer Alghabban, Abbott