FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Should a new form be prepared and signed when the OMB expiration date is reached? 1.57K viewsFDA 0 Votes 1 Ans Does FDA expect a double-sided 1572, or is a two-page document printed from the FDA website acceptable? 1.59K viewsFDA 0 Votes 1 Ans How should the 1572 be completed? 1.56K viewsFDA 0 Votes 1 Ans How should an investigator’s name appear on the 1572? 1.55K viewsFDA 0 Votes 1 Ans What address should be entered into Section #1? 1.51K viewsFDA 0 Votes 1 Ans Should co-investigators be listed on the 1572 in Section #1? Is it acceptable to have more than one investigator at a single site? 1.50K viewsFDA 0 Votes 1 Ans What is the purpose of Section #2? 1.62K viewsFDA 0 Votes 1 Ans What is the Statement of Investigator, Form FDA 1572? 1.55K viewsFDA 0 Votes 1 Ans Why does this form need to be completed by an investigator? 1.64K viewsFDA 0 Votes 1 Ans When must this form be completed and signed by an investigator? 1.60K viewsFDA 0 Votes 1 Ans Must the investigator be a physician? 1.45K viewsFDA 0 Votes 1 Ans What are the minimum qualifications of an investigator? 1.32K viewsFDA 0 Votes 1 Ans Does the 1572 need to be submitted to FDA? 1.26K viewsFDA 0 Votes 1 Ans When must a 1572 be updated or a new 1572 completed and signed by an investigator to reflect new or changed information? 1.40K viewsFDA 0 Votes 1 Ans When making corrections to documented entries, the only requirements are to sign, date, and leave original entry readable. Was there any discussion when writing Q7A to also record the reason for the change? Will field investigators expect this? 1.64K viewsFDA 0 Votes 1 Ans Did the FDA withdraw the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human Parenteral Drugs, Biological Products, and Medical Devices? 1.46K viewsFDA 0 Votes 1 Ans Can up to twelve month expiration-dating be assigned to oral solid and liquid dosage forms repackaged into unit-dose containers based on guidance in the May 2005 draft revision of Compliance Policy Guide, Section 480.200 (7132b.11), “Expiration Dating of Unit Dose Repackaged Drugs”? 1.48K viewsFDA 0 Votes 1 Ans Current requirements on the validation of computerised systems seen against the background of the new PIC/S Guidance “Good Practices for Computerised Systems in Regulated ‘GXP’ Environments” 1.58K viewsFDA 0 Votes 1 Ans What are the clinical trial information requirements for voluntary submissions under the regulation? 1.67K viewsFDA 0 Votes 1 Ans What is a “triggered” trial under the regulation? 1.36K viewsFDA « Previous 1 2 … 62 63 64 65 66 … 75 76 Next » Question and answer is powered by anspress.net
