Code of Federal Regulations Title 21. Food and Drugs § 21.329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act

(i) Patient identification code;

(ii) Patient age at the time of adverse drug experience, or date of birth;

(iii) Patient gender;  and

(iv) Patient weight.

(i) Outcome attributed to adverse drug event;

(ii) Date of adverse drug event;

(iii) Date of ICSR submission;

(iv) Description of adverse drug event (including a concise medical narrative);

(v) Adverse drug event term(s);

(vi) Description of relevant tests, including dates and laboratory data;  and

(vii) Other relevant patient history, including preexisting medical conditions.

(i) Name;

(ii) Dose, frequency, and route of administration used;

(iii) Therapy dates;

(iv) Diagnosis for use (indication);

(v) Whether the product is a combination product as defined in § 3.2(e) of this chapter;

(vi) Whether the product is a prescription or nonprescription product;

(vii) Whether adverse drug event abated after drug use stopped or dose reduced;

(viii) Whether adverse drug event reappeared after reintroduction of drug;

(ix) Lot number;

(x) Expiration date;

(xi) National Drug Code (NDC) number;  and

(xii) Concomitant medical products and therapy dates.

(i) Name, address, and telephone number;

(ii) Whether the initial reporter is a health care professional;  and

(iii) Occupation, if a health care professional.

(i) Name and contact office address;

(ii) Telephone number;

(iii) Report source, such as spontaneous;

(iv) Date the report was received by responsible person;

(v) Whether the ICSR is a 15–day report;

(vi) Whether the ICSR is an initial report or followup report;  and

(vii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s).