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DEFINITIONS--SOCRA19
CCRP/SOCRA
| Term | Definition |
|---|---|
| 21 CFR PART 11 | ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES |
| 21 CFR PART 50 | PROTECTION OF HUMAN SUBJECTS |
| 21 CFR PART 56 | INSTITUTIONAL REVIEW BOARD (IRB) |
| 21 CFR PART 312 | INVESTIGATIONAL NEW DRUG APPLICATION (IND) |
| 21 CFR PART 812 | INVESTIGATIONAL DEVICE EXEMPTIONS (IDE) |
| 45 CFR PART 46 SUBPART A | BASIC HHS POLICY FOR PROTECTION OF HUMAN RESEARCH SUBJECTS |
| 45 CFR PART 46 SUBPART B | ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN, HUMAN FETUSES AND NEONATES INVOLVED IN RESEARCH |
| 45 CFR PART 46 SUBPART C | ADDITIONAL PROTECTIONS PERTAINING TO BIOMEDICAL AND BEHAVIORAL RESEARCH INVOLVING PRISONERS AS SUBJECTS |
| 45 CFR PART 46 SUBPART D | ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED AS SUBJECTS IN RESEARCH |
| 45 CFR PART 46 SUBPART E | REGISTRATION OF INSTITUTIONAL REVIEW BOARDS |
| FDA FORM 482 | NOTICE OF FDA INSPECTION |
| FDA FORM 483 | INSPECTIONAL FDA OBSERVATIONS |
| FDA FORM 1572 | STATEMENT OF INVESTIGATOR |
| FDA FORM 3454 | CERTIFICATION- FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS |
| FDA FORM 3455 | DISCLOSURE- FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS |
| FDA FORM 3500 | VOLUNTARY REPORTING OF ADVERSE EVENTS AND PRODUCT PROBLEMS |
| FDA FORM 3500A | FOR USE BY USER-FACILITIES, DISTRIBUTORS, AND MANUFACTURERS FOR MANDATORY REPORTING |
| THE BELMONT REPORT | THIS REPORT DESCRIBES ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS. IT WAS CREATED BY THE NATIONAL COMMISION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH ON APRIL 18, 1979 |
| THE BELMON REPORT; PART A | BOUNDARIES BETWEEN PRACTICE AND RESEARCH |
| THE BELMON REPORT; PART B | BASIC ETHICAL PRINCIPLES |
| THE BELMON REPORT; PART C | APPLICATIONS |
| THE NUREMBERG CODE | THE NUREMBERG CODE IS A SET OF ETHICAL PRINCIPLES FOR HUMAN EXPERIMENTATION DEVELOPED IN 1947. |
| THE DECLARATION OF HELSINKI | THE DECLARATION, ORIGINALLY ADOPTED IN JUNE OF 1964, IS A SET OF ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS. IT HAS BEEN AMENDED A NUMBER OF TIMES SINCE THE ORIGINAL ADOPTION. |
| GOOD CLINICAL PRACTICE | GOOD CLINICAL PRACTICE (GCP) IS AN INTERNATIONAL ETHICAL AND SCIENTIFIC QUALITY STANDARD FOR DESIGNING, CONDUCTING, RECORDING AND REPORTING TRIALS THAT INVOLVE PARTICIPATION OF HUMAN SUBJECTS. |
| ADVERSE EVENT | ANY UNTOWARD MEDICAL OCCURRENCE IN A PATIENT OR CLINICAL INVESTIGATION SUBJECT ADMINISTERED A PHARMACEUTICAL PRODUCT AND WHICH DOES NOT NECESSARILY HAVE TO HAVE A CAUSAL RELATIONSHIP WITH THIS TREATMENT. |
| ADVERSE DRUG REACTION (ADR) IN PRE-APPROVAL CLINICAL EXPERIENCE: | ALL NOXIOUS AND UNINTENDED RESPONSES TO A MEDICINAL PRODUCT RELATED TO ANY DOSE SHOULD BE CONSIDERED ADVERSE DRUG REACTIONS. |
| ADVERSE DRUG REACTION (ADR) IN MARKETED MEDICINAL PRODUCTS: | A RESPONSE TO A DRUG WHICH IS NOXIOUS AND UNINTENDED AND WHICH OCCURS AT DOSES NORMALLY USED IN MAN FOR PROPHYLAXIS, DIAGNOSIS, OR THERAPY OF DISEASE OR FOR MODIFICATION OF PHYSIOLOGICAL FUNCTION. |
| UNEXPECTED ADVERSE DRUG REACTION | AN ADVERSE REACTION, THE NATURE OR SEVERITY OF WHICH IS NOT CONSISTENT WITH THE APPLICABLE PRODUCT INFORMATION |
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kendraskye1
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