Hi everyone,
I am working on my dissertation and need some help. I am working on a FDA Inspection dataset for clinical trials. There is one line per inspection (identified by inspection start/end date & FEI #, which uniquely identifies the firm and address) and FDA inspector. So If an inspection had 3 inspectors, the inspection would show up as 3 observations. I need help combining these inspections into one observation/line with one variable for each inspector.
Here is an example of an inspection that has two lines for the same inspection, but with two different FDA Employee conducting the inspections, so it shows up twice.
DISTRICT CENTER INSPNTYPE FORCAUSE INSPNSTART INSPNEND FDA483 CLASSIFICATION EMPLOYEEs FEI FIRMNAME FIRMADDRESS CITY ST ZIP COUNTRY INSPNLENGTH
DET-DO CDER SPONSOR N 24aug2009 24aug2009 N NAI Olenjack, Dawn C 3004552864 Covance Central Laboratoriy Services Inc. 8211 Scicor Dr Indianapolis IN 46214-2942 United States 1
DET-DO CDER SPONSOR N 24aug2009 24aug2009 N NAI Austin, Larry K 3004552864 Covance Central Laboratoriy Services Inc. 8211 Scicor Dr Indianapolis IN 46214-2942 United States 1
Once I combine these, I have a separate database excel sheet from FDA with the observations for each. That I am planning to combine using the 1 to many based on FEI and inspection end date. These are few examples of the variables for the second data set (excel sheet). There. could be no observations, 1, or many based on a given inspection identified by FEI # and inspection end date. Is this the right approach.
Any help would be much appreciated in combining this data. Thank you so much in advance.
Negin
I am working on my dissertation and need some help. I am working on a FDA Inspection dataset for clinical trials. There is one line per inspection (identified by inspection start/end date & FEI #, which uniquely identifies the firm and address) and FDA inspector. So If an inspection had 3 inspectors, the inspection would show up as 3 observations. I need help combining these inspections into one observation/line with one variable for each inspector.
Here is an example of an inspection that has two lines for the same inspection, but with two different FDA Employee conducting the inspections, so it shows up twice.
DISTRICT CENTER INSPNTYPE FORCAUSE INSPNSTART INSPNEND FDA483 CLASSIFICATION EMPLOYEEs FEI FIRMNAME FIRMADDRESS CITY ST ZIP COUNTRY INSPNLENGTH
DET-DO CDER SPONSOR N 24aug2009 24aug2009 N NAI Olenjack, Dawn C 3004552864 Covance Central Laboratoriy Services Inc. 8211 Scicor Dr Indianapolis IN 46214-2942 United States 1
DET-DO CDER SPONSOR N 24aug2009 24aug2009 N NAI Austin, Larry K 3004552864 Covance Central Laboratoriy Services Inc. 8211 Scicor Dr Indianapolis IN 46214-2942 United States 1
Once I combine these, I have a separate database excel sheet from FDA with the observations for each. That I am planning to combine using the 1 to many based on FEI and inspection end date. These are few examples of the variables for the second data set (excel sheet). There. could be no observations, 1, or many based on a given inspection identified by FEI # and inspection end date. Is this the right approach.
| FEI | INSPN DATE | CFR/FDCA NUM | SHORT DESC | LONG DESC |
| 1036465 | 8/13/2010 | 21 CFR 812.100 | Investigator lack of informed consent | Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. |
| 1036465 | 8/13/2010 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations | An investigation was not conducted according to the investigational plan. |
| 1038833 | 8/21/2008 | 21 CFR 812.150(b)(1) | Sponsor evaluation rpt not timely, distributed | Reports of the results of evaluation of unanticipated adverse device effects were not all submitted to FDA and all reviewing IRBs. |
| 1038833 | 8/21/2008 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures | There are no written procedures for monitoring an investigational device study. |
| 1038833 | 8/21/2008 | 21 CFR 812.40 | Sponsors' general responsibilities | For an investigational study, proper monitoring was not ensured. |
| 1038833 | 8/21/2008 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement | A signed agreement was not obtained from each participating investigator that includes sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement and a commitment to promptly update financial disclosure information if any relevant changes occur during the investigation and for one year following completion of the study. |
Any help would be much appreciated in combining this data. Thank you so much in advance.
Negin
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